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Prophylactic Antibiotics on Urethral Catheter Withdrawal

Information source: St. Antonius Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Tract Infection; Bacteriuria

Intervention: trimethoprim-sulfamethoxazole (Drug); ciprofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: St. Antonius Hospital

Official(s) and/or principal investigator(s):
M. Tersmette, MD, PhD, Study Director, Affiliation: Sint Antonius Hospital, Nieuwegein


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.

Clinical Details

Official title: Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Symptomatic bacteriuria

Asymptomatic bacteriuria

Secondary outcome: Antibiotic resistance patterns

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Sint Antonius Hospital, Nieuwegein, Utrecht 3430 EM, Netherlands
Additional Information

Starting date: January 2005
Last updated: April 18, 2007

Page last updated: August 23, 2015

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