Prophylactic Antibiotics on Urethral Catheter Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Tract Infection Bacteriuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trimethoprim-sulfamethoxazole

Intervention Type DRUG

ciprofloxacin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

M. Tersmette, MD, PhD

Role: STUDY_DIRECTOR

Sint Antonius Hospital, Nieuwegein

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sint Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAD-Trial

Identifier Type: -

Identifier Source: secondary_id

2005-01