- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03174795
A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection
May 11, 2018 updated by: Hoffmann-La Roche
A Non-Randomized, Open-Label, One Treatment, One Group Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Patients With a Complicated Urinary Tract Infection
This is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cUTI) including pyelonephritis to characterize the pharmacokinetics of RO7079901 co-administered with meropenem.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
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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Budapest, Hungary, 1115
- Szent Imre Egyetemi Oktatokorhaz
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Budapest, Hungary, 1083
- Semmelweis University, First Dept of Medicine
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Debrecen, Hungary, 4012
- Kenezy Gyula Korhaz-Rend. Eges. Szol.; Klinikai Farm. Infek. es Allerg. Intezet
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Liepaja, Latvia, 3414
- Liepaja Regional Hospital
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Riga, Latvia, LV-1002
- P.Stradina Kliniska Uni Tes Slimnica; Latvian Center of Nephrology
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Riga, Latvia, LV1006
- Riga East Clinical University Hospital
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Bydgoszcz, Poland, 85-094
- Klinika Urologii Ogólnej: Collegium Medicum Uniwersytetu Mikołaja Kopernika w Toruniu; Urology
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Warszawa, Poland, 02-005
- Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii
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Łódź, Poland, 92-213
- Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek
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Belgrade, Serbia, 11080
- Clinical Hospital Center Bezanijska Kosa
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Belgrade, Serbia, 11080
- Clinical Center Zemun
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Belgrade, Serbia, 11000
- Clinical Center of Serbia; Clinic of Urology
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California
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La Mesa, California, United States, 91942
- eStudySite
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Florida
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Requiring hospitalization for IV antibacterial therapy for the treatment of presumed/confirmed cUTI (including pyelonephritis)
- Clinical signs and/or symptoms of pyelonephritis or a cUTI
- Urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (>)1x10^5 colony forming units (CFU) per milliliter (CFU/mL) of a gram negative organism
- Negative urine pregnancy test result confirmed by a blood test
- Agreement to remain abstinent or use a contraceptive method
Exclusion Criteria:
- Has a concomitant infection requiring antibacterial therapy, in addition to study drug
- Confirmed fungal urinary tract infection
- Moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant
- Documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy
- Any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the Investigator, unlikely to survive the study period
- Urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry
- Urinary tract infection (UTI) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis)
- Suspected or confirmed perinephric or intra renal abscess
- Complete obstruction of any portion of the urinary tract, or a permanent urinary diversion
- History of epilepsy, brain lesions or other significant neurological disorders
- Use of probenecid within the 7 days before enrollment
- Known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic
- Any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study
- Women who are pregnant, planning to become pregnant, or lactating
- Participation in a clinical study of an investigational drug or device within one month prior to enrollment
- Prior enrollment in this study
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: RO7079901 and Meropenem
Participants will receive RO7079901 and meropenem.
The duration of study drug treatment will be determined by the investigator after evaluation of the participant's response to study drug treatment.
Participants should receive a minimum treatment period of 3 days and up to 14 days of intravenous (IV) study drug treatment.
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Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.
Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUC0-tau) of RO7079901
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Total Clearance (CL) of RO7079901
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Renal Clearance (CLr) of RO7079901
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Maximum Observed Plasma Concentration (Cmax) of RO7079901
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Cumulative Amount Excreted in Urine Over the Dosing Interval (Ae) of RO7079901
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Fraction Excreted into the Urine (Fe) of RO7079901
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Time of Maximum Observed Plasma Concentration (Tmax) of RO7079901
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Steady State Volume of Distribution (Vss) of RO7079901
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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AUC0-tau of Meropenem
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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CL of Meropenem
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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CLr of Meropenem
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Cmax of Meropenem
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Ae of Meropenem
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Fe of Meropenem
Time Frame: Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Days 1 and 3 (all urine passed in the 8-hour period after morning dose will be collected)
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Tmax of Meropenem
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Vss of Meropenem
Time Frame: Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Pre-dose (0 hr), 1.5 hr (end of infusion [infusion duration=1.5 hr]), 3, 4.5, 6, 8 hr post dose on Days 1, 3; pre-dose (0 hr), 1.5 and 8 hr post dose on Days 5 and 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 11, 2017
Primary Completion (Actual)
December 4, 2017
Study Completion (Actual)
December 16, 2017
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
May 15, 2018
Last Update Submitted That Met QC Criteria
May 11, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP39596
- 2016-004478-16 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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