Prophylactic Antibiotics on Urethral Catheter Withdrawal - Full Text View

Sponsor:	St. Antonius Hospital
Information provided by:	St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT00126698

Purpose

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

MedlinePlus related topics: Antibiotics Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126698

Locations

Netherlands
Sint Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM

Sponsors and Collaborators

St. Antonius Hospital

Investigators

Study Director:

M. Tersmette, MD, PhD

Sint Antonius Hospital, Nieuwegein

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00126698 History of Changes
Other Study ID Numbers:	2005-01, CAD-Trial
Study First Received:	August 2, 2005
Last Updated:	April 18, 2007
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:

Bacteriuria
Urinary Catheter
Urinary tract infection
Prophylaxis
Urinary catheter removal

Additional relevant MeSH terms:

Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on February 09, 2012