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Multifaceted Treatment of Catheter-related Urinary Tract Infection

NCT00732238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-02-16

Study results available
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Summary

The specific objective of this clinical trial is to demonstrate that a multifaceted approach for treatment for catheter-related urinary tract infection (UTI) in patients with spinal cord injury is effective and feasible. We plan to test the following hypothesis: a multifaceted treatment approach that consists of immediate removal of the indwelling bladder catheter, selecting antibiotics based on the finding from a urine culture that is obtained through the newly inserted catheter, and a 5-day course of systemic antibiotics will effectively treat catheter-related infection that is limited to the lower urinary tract of patients with spinal cord injury.

Conditions

Interventions

OTHER

Shortened course of antibiotic therapy

By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse.

OTHER

Standard Therapy

Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter.

Sponsors & Collaborators

Principal Investigators

  • Rabih O Darouiche, MD · Michael E. DeBakey VA Medical Center (152)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732238 on ClinicalTrials.gov