Phase 2
N=61
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Spinal Cord Injury · Neurogenic Bladder · Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT00732238 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: 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 — 28; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Shortened course of antibiotic therapy (Other); Standard Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
28; 27 | — |
| SECONDARY The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy |
9; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Exclusion criteria will include septicemia, chronic antimicrobial therapy and inability, or unwillingness to give informed consent
Data sourced from ClinicalTrials.gov (NCT00732238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.