Prophylactic Antibiotics on Urethral Catheter Withdrawal

St. Antonius Hospital

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection; Bacteriuria

Treatments: Drug: ciprofloxacin; Drug: trimethoprim-sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00126698

CAD-Trial

2005-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind