- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00126698
Prophylactic Antibiotics on Urethral Catheter Withdrawal
April 18, 2007 updated by: St. Antonius Hospital
Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Utrecht
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Nieuwegein, Utrecht, Netherlands, 3430 EM
- Sint Antonius Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Symptomatic bacteriuria
|
Asymptomatic bacteriuria
|
Secondary Outcome Measures
Outcome Measure |
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Antibiotic resistance patterns
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: M. Tersmette, MD, PhD, Sint Antonius Hospital, Nieuwegein
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
August 2, 2005
First Submitted That Met QC Criteria
August 3, 2005
First Posted (Estimate)
August 4, 2005
Study Record Updates
Last Update Posted (Estimate)
April 19, 2007
Last Update Submitted That Met QC Criteria
April 18, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Urologic Diseases
- Urinary Tract Infections
- Bacteriuria
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Ciprofloxacin
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- 2005-01
- CAD-Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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