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...
Date First Received: August 2, 2005
Last Updated: April 18, 2007
Verified by: St. Antonius Hospital, April 2007
Clinical Trial Phase: Phase 4 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 100
Brief Summary
Official Title: “Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: trimethoprim-sulfamethoxazole
- Drug: ciprofloxacin
Outcome Measures for this Clinical Trial
Primary Measures
- Symptomatic bacteriuria
- Asymptomatic bacteriuria
Secondary Measures
- Antibiotic resistance patterns
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: St. Antonius Hospital
Overall Clinical Trial Officials and Contacts
M. Tersmette, MD, PhD Study Director Sint Antonius Hospital, Nieuwegein
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00126698
Study ID Number: 2005-01
ClinicalTrials.gov Identifier: NCT00126698
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Authorship and Review
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