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