- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599806
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
August 31, 2017 updated by: Pfizer
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
Study Overview
Status
Completed
Detailed Description
A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults
Study Type
Interventional
Enrollment (Actual)
641
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rosario, Argentina
- Research Site
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Pazardzhik, Bulgaria
- Research Site
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Sofia, Bulgaria
- Research Site
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Veliko Tarnovo, Bulgaria
- Research Site
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Slavonski Brod, Croatia
- Research Site
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Zadar, Croatia
- Research Site
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Zagreb, Croatia
- Research Site
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Liberec, Czechia
- Research Site
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Praha, Czechia
- Research Site
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Hamburg, Germany
- Research Site
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Haifa, Israel
- Research Site
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Kfar-saba, Israel
- Research Site
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Modena, Italy
- Research Site
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Busan, Korea, Republic of
- Research Site
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Jeonnam, Korea, Republic of
- Research Site
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Seoul, Korea, Republic of
- Research Site
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Cuernavaca, MOR, Mexico
- Research Site
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Guadalajara, Mexico
- Research Site
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Zapopan, Mexico
- Research Site
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Arequipa, Peru
- Research Site
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Cercardo de Lima, Peru
- Research Site
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Cusco, Peru
- Research Site
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Lima, Peru
- Research Site
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Trujillo, Peru
- Research Site
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Białystok, Poland
- Research Site
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Sochaczew, Poland
- Research Site
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Wrocław, Poland
- Research Site
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Bucharest, Romania
- Research Site
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Bucuresti, Romania
- Research Site
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Oradea, Romania
- Research Site
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Sibiu, Romania
- Research Site
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Timisoara, Romania
- Research Site
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Moscow, Russian Federation
- Research Site
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Nizhniy Novgorod, Russian Federation
- Research Site
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Novosibirsk, Russian Federation
- Research Site
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Saint-Petersburg, Russian Federation
- Research Site
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Smolensk, Russian Federation
- Research Site
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St. Petersburg, Russian Federation
- Research Site
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St.-Petersburg,, Russian Federation
- Research Site
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Tomsk, Russian Federation
- Research Site
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Velikiy Novgorod, Russian Federation
- Research Site
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Alicante, Spain
- Research Site
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Alzira (Valencia), Spain
- Research Site
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Barcelona, Spain
- Research Site
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Elche, Spain
- Research Site
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Granada, Spain
- Research Site
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Terrassa, Spain
- Research Site
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Kaohsiung, Taiwan
- Research Site
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Taipei, Taiwan
- Research Site
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Chernivtsi, Ukraine
- Research Site
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Ivano-Frankivsk, Ukraine
- Research Site
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Kharkiv, Ukraine
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Kyiv, Ukraine
- Research Site
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Lutsk, Ukraine
- Research Site
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Simferopol, Ukraine
- Research Site
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Vinnytsia, Ukraine
- Research Site
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Zaporizhzhya, Ukraine
- Research Site
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Michigan
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Detroit, Michigan, United States
- Research Site
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Missouri
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Saint Louis, Missouri, United States
- Research Site
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Pennsylvania
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Indiana, Pennsylvania, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 90 years of age inclusive
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
- Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis
Exclusion Criteria:
- Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
- Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
- Patient is immunocompromised
- Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ceftazidime - Avibactam ( CAZ-AVI)
IV treatment
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Ceftazidime 2000 mg and 500 mg of avibactam.
Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
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Active Comparator: Doripenem
IV treatment
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Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
500 mg of Doripenem.
Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test
Time Frame: At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
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Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set.
The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
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At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.
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Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set.
The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a favorable per patient microbiological response at TOC.
The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a favorable per-patient microbiological response at EOT (IV)
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-patient Microbiological Response at LFU (mMITT Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a favorable per patient microbiological response at LFU
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a favorable per-patient microbiological response at EOT (IV)
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a favorable per patient microbiological response at TOC
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a favorable per patient microbiological response at LFU
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a favorable per-patient microbiological response at EOT (IV)
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a favorable per patient microbiological response at TOC
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a favorable per patient microbiological response at LFU
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a clinical cure at EOT (IV).
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Investigator Determined Clinical Response at TOC (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a clinical cure at TOC.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at LFU (mMITT Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a clinical cure at LFU.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a clinical cure at EOT (IV).
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a clinical cure at TOC.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a clinical cure at LFU.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a clinical cure at EOT (IV).
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a clinical cure at TOC.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a clinical cure at LFU.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of patients with a clinical cure at EOT (IV).
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of patients with a clinical cure at TOC.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of patients with a clinical cure at LFU.
The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)
Time Frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.
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Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)
Time Frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.
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Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)
Time Frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.
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Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)
Time Frame: Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.
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Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.
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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)
Time Frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set
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At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
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Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set
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At TOC visit. TOC visit is 21 to 25 days from Randomization
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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization
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Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set
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At LFU visit. LFU visit is 45 to 52 days from Randomization
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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)
Time Frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set
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At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set
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At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
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Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set
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At TOC visit. TOC visit is 21 to 25 days from Randomization.
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Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set
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At LFU visit. LFU visit is 45 to 52 days from Randomization.
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Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)
Time Frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only
|
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization
|
Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only
|
At LFU visit. LFU visit is 45 to 52 days from Randomization
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)
Time Frame: At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only
|
At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
|
Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only
|
At TOC visit. TOC visit is 21 to 25 days from Randomization.
|
Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
|
Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only
|
At LFU visit. LFU visit is 45 to 52 days from Randomization.
|
Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)
Time Frame: At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only
|
At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy
|
Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization.
|
Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only
|
At TOC visit. TOC visit is 21 to 25 days from Randomization.
|
Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)
Time Frame: At LFU visit. LFU visit is 45 to 52 days from Randomization.
|
Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only
|
At LFU visit. LFU visit is 45 to 52 days from Randomization.
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)
Time Frame: At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set
|
At TOC visit. TOC visit is 21 to 25 days from Randomization
|
Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)
Time Frame: within 15 minutes before/after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
within 15 minutes before/after dose
|
Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)
Time Frame: Between 30 to 90 minutes after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
Between 30 to 90 minutes after dose
|
Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)
Time Frame: Between 300 to 360 minutes after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
Between 300 to 360 minutes after dose
|
Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)
Time Frame: within 15 minutes before/after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
within 15 minutes before/after dose
|
Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)
Time Frame: Between 30 to 90 minutes after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
Between 30 to 90 minutes after dose
|
Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)
Time Frame: Between 300 to 360 minutes after dose
|
Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.
|
Between 300 to 360 minutes after dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
- Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
- Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
- Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
- Wagenlehner FM, Sobel JD, Newell P, Armstrong J, Huang X, Stone GG, Yates K, Gasink LB. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program. Clin Infect Dis. 2016 Sep 15;63(6):754-762. doi: 10.1093/cid/ciw378. Epub 2016 Jun 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
May 15, 2012
First Submitted That Met QC Criteria
May 15, 2012
First Posted (Estimate)
May 16, 2012
Study Record Updates
Last Update Posted (Actual)
September 6, 2017
Last Update Submitted That Met QC Criteria
August 31, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Nephritis
- Nephritis, Interstitial
- Pyelitis
- Infections
- Communicable Diseases
- Urinary Tract Infections
- Pyelonephritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Cytochrome P-450 CYP1A2 Inhibitors
- beta-Lactamase Inhibitors
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Ciprofloxacin
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
- Avibactam
- Ceftazidime
- Doripenem
Other Study ID Numbers
- D4280C00004
- 2011-005722-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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