Prophylactic Antibiotics on Urethral Catheter Withdrawal

Phase 4

Completed

• Conditions: Urinary Tract Infection; Bacteriuria

• Registration Number: NCT00126698
• Lead Sponsor: St. Antonius Hospital

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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-04
• Status Verified: 2007-04
• Study Completion: 2007-04
• Last Update Submitted: 2007-04-18
• Last Update Posted: 2007-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)
• Fever
• Symptomatic urinary tract infection
• Antibiotic use ≤ 48 hours before urinary catheter removal
• Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
• Urologic pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptomatic bacteriuria
Asymptomatic bacteriuria

Secondary Outcome Measures

Name	Time	Method
Antibiotic resistance patterns

Trial Locations

Locations (1)

Sint Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands