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Prophylactic Antibiotics on Urethral Catheter Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126698
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : April 19, 2007
Information provided by:
St. Antonius Hospital

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacteriuria Drug: trimethoprim-sulfamethoxazole Drug: ciprofloxacin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial
Study Start Date : January 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Symptomatic bacteriuria
  2. Asymptomatic bacteriuria

Secondary Outcome Measures :
  1. Antibiotic resistance patterns

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126698

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Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
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Study Director: M. Tersmette, MD, PhD Sint Antonius Hospital, Nieuwegein

Layout table for additonal information Identifier: NCT00126698     History of Changes
Other Study ID Numbers: 2005-01
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007
Keywords provided by St. Antonius Hospital:
Urinary Catheter
Urinary tract infection
Urinary catheter removal
Additional relevant MeSH terms:
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Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors