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OpenTrials
Completed

NCT Number: NCT00126698

Prophylactic Antibiotics on Urethral Catheter Withdrawal

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sint Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim-sulfamethoxazole

Drug

Ciprofloxacin

Drug

Primary outcomes

  1. Symptomatic bacteriuria

  2. Asymptomatic bacteriuria

Secondary outcomes

  1. Antibiotic resistance patterns

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Aug 4, 2005
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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