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NCT00037921 · ClinicalTrials.gov registry record · Phase 2
UTI Prophylaxis Using Bacterial Interference Following SCI
A Phase 2 study of Urinary Tract Infections, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00037921: Completed Phase 2 study of Urinary Tract Infections, sponsored by US Department of Veterans Affairs.
NCT00037921 is a Phase 2 study of Urinary Tract Infections that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 40 participants, below the 457-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00037921, a Phase 2 study of Urinary Tract Infections, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria. We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).
Conditions Studied
Interventions
- PROCEDURE Bacterial colonization
Study Locations (1)
Texas
- Michael E. DeBakey VA Medical Center (152) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-01 |
| Est. Completion | 2003-12 |
| Phase | Phase 2 |
What the finished NCT00037921 record still lists
NCT00037921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 457-participant average among 34 other Urinary Tract Infections trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Urinary Tract Infections appearing as the primary indexed condition, and to 1 intervention - of which Bacterial colonization is the first listed.
NCT00037921 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00037921 about?
NCT00037921 is a clinical study titled "UTI Prophylaxis Using Bacterial Interference Following SCI". Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of U...
What is the current status of trial NCT00037921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-01. Estimated completion is 2003-12.
What conditions does trial NCT00037921 study?
This clinical trial studies the following conditions: Urinary Tract Infections.
What interventions are being tested in trial NCT00037921?
The interventions under investigation include: Bacterial colonization (PROCEDURE).
Who is sponsoring clinical trial NCT00037921?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00037921 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00037921's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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