NCT00126698CompletedPhase 4
Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- St. Antonius Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Symptomatic bacteriuria
Study Overview
Brief Summary
Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.
Detailed Description
Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The researchers undertake a double-blind, placebo-controlled trial to assess the efficacy of single-dose therapy of trimethoprim-sulfamethoxazole or ciprofloxacin, versus placebo therapy in selected groups of surgical patients who had bladder drainage scheduled to last longer than 3 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Urethral catheter in situ for at least 3 days (72h)
Exclusion Criteria
- •Pregnancy
- •Impaired renal or hepatic function (serum creatinine > 150 mmol/l, serum transaminases > 75 IU/l)
- •Symptomatic urinary tract infection
- •Antibiotic use ≤ 48 hours before urinary catheter removal
- •Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
- •Urologic pathology
Outcomes
Primary Outcomes
Symptomatic bacteriuria
Asymptomatic bacteriuria
Secondary Outcomes
- Antibiotic resistance patterns
Investigators
Study Sites (2)
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