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Prophylactic Antibiotics on Urethral Catheter Withdrawal

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00126698
Enrollment
100
Registered
2005-08-04
Start date
2005-01-31
Completion date
2007-04-30
Last updated
2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteriuria, Urinary Tract Infection

Keywords

Bacteriuria, Urinary Catheter, Urinary tract infection, Prophylaxis, Urinary catheter removal

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.

Interventions

DRUGtrimethoprim-sulfamethoxazole
DRUGciprofloxacin

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Symptomatic bacteriuria
Asymptomatic bacteriuria

Secondary

MeasureTime frame
Antibiotic resistance patterns

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026