Status:
COMPLETED
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Complicated Urinary Tract Infection
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
June 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2010
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00921024
Start Date
June 30 2009
End Date
March 11 2010
Last Update
October 18 2018
Active Locations (21)
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1
Healthcare Partners Medical Group
Los Angeles, California, United States, 90015
2
Compass Research, LLC
Orlando, Florida, United States, 32806
3
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States, 30030
4
Infectious Disease of Indiana, PSC
Indianapolis, Indiana, United States, 46280