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:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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, Utrecht
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

Study ID Numbers:	2005-01, CAD-Trial
Study First Received:	August 2, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00126698 History of Changes
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:

Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Trimethoprim
Molecular Mechanisms of Pharmacological Action
Sulfamethoxazole
Urinary Tract Infections
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Trimethoprim-Sulfamethoxazole Combination
Folic Acid Antagonists

Renal Agents
Infection
Pharmacologic Actions
Antimalarials
Anti-Bacterial Agents
Ciprofloxacin
Antiparasitic Agents
Urologic Diseases
Therapeutic Uses
Bacteriuria
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010