Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
- Conditions
- Complicated Urinary Tract Infection
- Interventions
- Registration Number
- NCT00921024
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
- Detailed Description
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.
Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
-
Males and females 18 to 90 years of age, inclusive.
-
Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power field in spun urine)
-
Clinical signs and/or symptoms of cUTI, either of:
a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;
OR
b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:
- Dysuria;
- Frequency;
- Suprapubic pain;
- Urgency
ii. At least one of the following complicating factors:
- Male gender;
- Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
- Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
- Urogenital surgery within 7 days preceding administration of the first dose of study drug;
- Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.
Exclusion Criteria
- Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
- Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
- Complete, permanent obstruction of the urinary tract
- Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
- Suspected or confirmed perinephric or intrarenal abscess
- Suspected or confirmed prostatitis
- Known ileal loop or vesico-ureteral reflux
- Women who are pregnant or nursing
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CXA-101 CXA-101 2 Ceftazidime Ceftazidime
- Primary Outcome Measures
Name Time Method Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population TOC; 6-9 days after last study drug administration Microbiological response is eradication for each baseline pathogen
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population. TOC; 6-9 days after last study drug administration Microbiological response is eradication for each baseline pathogen
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych
🇵🇱Warszawa, Poland
Szpital Praski p.w. Przemienienia Pańskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej ll Oddział Wewnętrznych
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Wojewódźki im. Papieża Jana Pawła ll Oddział Wewnętrznych Nefrologiczno-Endokrynologiczny ze Stacją Dializ
🇵🇱Zamość, Poland
Szpital Kliniczny Dzieciątka Jezus-Centrum Leczenia Obrażeń Klinika Urologii Ogólnej, Onkologicznej Czynnościowej
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii
🇵🇱Lublin, Poland
Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny
🇵🇱Wrocław, Poland
Mississippi Medical Research, LLC
🇺🇸Picayune, Mississippi, United States
Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych
🇵🇱Tychy, Poland
Healthcare Partners Medical Group
🇺🇸Los Angeles, California, United States
Remington-Davis, Inc. Clinical Research
🇺🇸Columbus, Ohio, United States
Great Falls Clinic, LLP
🇺🇸Butte, Montana, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Atlanta Institute for Medical Research, Inc.
🇺🇸Decatur, Georgia, United States
Infectious Disease of Indiana, PSC
🇺🇸Indianapolis, Indiana, United States
Kreiskrankenhaus Backnang
🇩🇪Backnang, Germany
Universitätsklinikum Schleswig Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Urologische Klinik Dr. Castringius München-Planegg
🇩🇪Planegg, Germany
Brüderkrankenhaus St. Josef Paderborn
🇩🇪Paderborn, Germany
URO Forschungs GmbH
🇩🇪Berlin, Germany
Uniklinikum Giessen
🇩🇪Giessen, Germany
Evangelisches Krankenhaus Giessen Urologie
🇩🇪Giessen, Germany