- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505683
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
August 7, 2020 updated by: Sihuan Pharmaceutical Holdings Group Ltd.
A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 2
- 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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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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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
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects aged 18-75 years
Have a diagnosis of cUTI or AP as defined below:
cUTI definition:
At least Two of the following signs and symptoms:
- Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C)
- Flank pain or Lower abdominal pain
- Dysuria, urgency to void, or increased urinary frequency
- Nausea or vomiting
- Costovertebral angle tenderness or renal percussive pain on physical examination.
- Blood leukocytes above upper limit of normal value
And at least One of the following risk factors for cUTI:
- Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters prior to Screening should be expected to remove during study period
- post-void residual urine volume of ≥ 100 mL;
- Obstructive uropathy (e.g. bladder outlet obstruction, nephrolithiasis, prostatic hyperplasia) that is expected to be removed during study drug therapy;
- Perioperative urinary tract infection.
AP definition: And at least One of the following signs and symptoms:
- Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C);
- Flank pain
- Dysuria, urgency to void, or increased urinary frequency
- Nausea or vomiting
- Costovertebral angle tenderness or renal percussive pain on physical examination.
- Blood leukocytes above upper limit of normal value
- Patients or legal representatives can be able to provide informed consent
Exclusion Criteria:
- Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to randomization
- Anticipated concomitant use of other systemic antibiotic drugs during the study period
- Anticipated continnue to preventive anti-infectious therapy after cUTI patients completed investigational drug treatment
Presence of any known or suspected disease or condition as following:
- Uncomplicated urinary tract infection (uUTI)
- Fungal Urinary tract infection
- Perinephric or renal corticomedullary abscess
- Polycystic kidney disease
- Urinary tuberculosis
- Obstructive uropathy(e.g.congenital malformation) unable to remove during treatment.
- Ideal loop surgery or vesicoureteral reflux
- Permannent bladder catheterization or long term indwelling nephrostomy tube
- Previous or planned renal transplantation
- Patients undergoing dialysis"
- Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
- Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis
- Confirmed or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia)
- Trauma to the pelvis or urinary tract within 7days before enrollment
- Rapid onset or life-threatening diseases, such as septic shock, respiratory failure, sepsis, etc;
- Severe cardiovascular and cerebrovascular diseases, acute myocardial infarction, acute ischemic stroke, acute Hemorrhagic stroke or intravascular intervention within recently 3 months
- Known or suspected central nerve system disorders, prone to epilepsy(e.g severe carebral arteriosclerosis)
- Known history of immunodeficiency diease, e.g.AIDS or human immunodeficiency virus (HIV) infection,hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long term use of systemic corticosteroids;
- Use of valproic acid or probenecid within 30 days before enrollment or during study period.
Hepatic impairment at Screening, evidenced as:
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN);
- total bilirubin >1.5x ULN;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) and total bilirubin > ULN; Creatinine clearance (CrCl) of <60 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL])
- Known allergic to β-lactam drugs or in an allergic state
- Confirmed or suspected alcohol or drug abuse history
- Patients with other mental disorders who are unable or unwilling to cooperate.
- Pregnant or breastfeeding women or plan to pregnant and unwilling to take contraceptive methods
- Participants in other clinical trials within 3 months before enrollment.
- Other situations that the investigators considers not suitable to participate in this clinical trial.
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 |
---|---|
Experimental: test drug arm
Benapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.
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Benapenem for IV injection administered as a 1-gram IV infusion
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Active Comparator: active control arm
Ertapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.
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Ertapenem for IV injection administered as a 1-gram IV infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with clinical cure at test-of-cure (TOC) visit
Time Frame: Day 7 +/- 1 days after the end of treatment
|
Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
|
Day 7 +/- 1 days after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 13, 2018
Primary Completion (Actual)
May 8, 2020
Study Completion (Actual)
May 8, 2020
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 7, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
August 10, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5081-II-2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
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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