Multifaceted Treatment of Catheter-related Urinary Tract Infection

NCT00732238 | Completed Phase 2 Results

• 2 other identifiers: B4747-PH-18309
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Spinal Cord Injury; Neurogenic Bladder; Urinary Tract Infection

Keywords

Spinal Cord Injury; Urinary Tract Infection; Catheter Dependent

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect

  Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)

Secondary Outcomes (1)

• The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy

  Up to 180 days of end of therapy

Study Arms (2)

Arm 1

EXPERIMENTAL

Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.

Other: Shortened course of antibiotic therapy

Arm 2

ACTIVE COMPARATOR

Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.

Other: Standard Therapy

Interventions

Shortened course of antibiotic therapy OTHER

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.

Arm 1

Standard Therapy OTHER

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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Tract Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Rabih Darouiche
• Organization: Michael E DeBakey VA Medical Center-Baylor College of Medicine

rdarouiche@aol.com

713-841-3882

Study Officials

• Rabih O Darouiche, MD

  Michael E. DeBakey VA Medical Center (152)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 16, 2015
• Results First Posted: November 3, 2014

Record last verified: 2015-01

Locations

US (1)