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Prophylactic Antibiotics on Urethral Catheter Withdrawal

This study has been completed.
Information provided by:
St. Antonius Hospital Identifier:
First received: August 2, 2005
Last updated: April 18, 2007
Last verified: April 2007
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 Intervention Phase
Urinary Tract Infection Bacteriuria Drug: trimethoprim-sulfamethoxazole Drug: ciprofloxacin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Symptomatic bacteriuria
  • Asymptomatic bacteriuria

Secondary Outcome Measures:
  • Antibiotic resistance patterns

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: April 2007
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00126698

Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Study Director: M. Tersmette, MD, PhD Sint Antonius Hospital, Nieuwegein
  More Information Identifier: NCT00126698     History of Changes
Other Study ID Numbers: 2005-01
Study First Received: August 2, 2005
Last Updated: April 18, 2007

Keywords provided by St. Antonius Hospital:
Urinary Catheter
Urinary tract infection
Urinary catheter removal

Additional relevant MeSH terms:
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
Cytochrome P-450 CYP2C8 Inhibitors processed this record on August 18, 2017