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Cipro XR for Complicated Urinary Tract Infections
NCT00481689Phase 4
Key facts
- Status
- Completed
- Start
- May 2004
- Countries
- 1
- Sponsor
- Bayer
- Modality
- Small Molecules
- Drugs
- ciprofloxacin
- Conditions
- complicated urinary tract infection (cUTI)
01
Overview
Phase 4, open-label, single-arm trial of ciprofloxacin in complicated urinary tract infection (cUTI), sponsored by Bayer. Primary endpoint: Safety and efficacy of ciprofloxacin XR. Started May 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Cipro XR Arm
Patients receive Ciprofloxacin XR 1000 mg daily
03
Who it enrols
Adults with suspected complicated UTI, pyuria, and positive culture for Pseudomonas aeruginosa or other pathogens, with at least one underlying condition (catheter, retention, neurogenic bladder, etc.). Excludes pregnant women, those with pyelonephritis, sepsis, or resistant pathogens.
04
Endpoints
Primary
Safety and efficacy of ciprofloxacin XR
Secondary
Clinical response at Test of Cure
Clinical response post-treatment
Adverse Event collection
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