Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Completed · Phase 2
Conditions studied: Complicated Urinary Tract Infection
In brief
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
Key facts
- Study ID
- NCT00921024
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 129
- Starts
- 2009-06-30
- Expected to finish
- 2010-03-11
- Last updated by the study team
- 2018-10-18
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Healthcare Partners Medical Group — Los Angeles, California, 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
- Mississippi Medical Research, LLC — Picayune, Mississippi, United States
- Great Falls Clinic, LLP — Butte, Montana, United States
- Remington-Davis, Inc. Clinical Research — Columbus, Ohio, United States
- Kreiskrankenhaus Backnang — Backnang, Germany
- URO Forschungs GmbH — Berlin, Germany
- Uniklinikum Giessen — Giessen, Germany
- Evangelisches Krankenhaus Giessen Urologie — Giessen, Germany
- Universitätsklinikum Schleswig Holstein Campus Lübeck — Lübeck, Germany
- Brüderkrankenhaus St. Josef Paderborn — Paderborn, Germany
- Urologische Klinik Dr. Castringius München-Planegg — Planegg, Germany
- Samodzielny Publiczny Szpital Kliniczny nr 4 Katedra i Klinika Nefrologii — Lublin, Poland
- Wojewódźki Szpital Specjalistyczny nr 1 Oddział Chorób Wewnętrznych — Tychy, Poland
- Szpital Bielański im.Ks. Jerzego Popiełuszki Samodzielny Publiczny Zakład Opieki Zdrowotnej IV Kliniczny Oddzial Chorób Wewnętrznych — Warsaw, Poland
- Szpital Kliniczny Dzieciątka Jezus-Centrum Leczenia Obrażeń Klinika Urologii Ogólnej, Onkologicznej Czynnościowej — Warsaw, Poland
- Szpital Praski p.w. Przemienienia Pańskiego Samodzielny Publiczny Zakład Opieki Zdrowotnej ll Oddział Wewnętrznych — Warsaw, Poland
- Wojewódźki Szpital Specjalistyczny Oddział Nefrologiczny — Wroclaw, Poland
- Samodzielny Publiczny Szpital Wojewódźki im. Papieża Jana Pawła ll Oddział Wewnętrznych Nefrologiczno-Endokrynologiczny ze Stacją Dializ — Zamość, Poland
Full record on ClinicalTrials.gov
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