Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00458471 · ClinicalTrials.gov registry record · Phase 1

E. Coli for Prevention of Catheter UTI in SCI Patients

A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00458471 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 12 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00458471, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

The overall goal of this project is to develop a new approach for the prevention of urinary tract infection (UTI) in persons who rely on indwelling catheters for bladder drainage. Veterans with spinal cord injury (SCI) frequently require chronic bladder catheterization. Most individuals with SCI have neurogenic bladders, and the resulting urinary stasis and bladder catheterization predispose them to recurrent UTI.1 The presence of a urinary catheter dramatically increases the risk of UTI, not only through contamination of the urinary tract during catheter changes, but also by the presence of a foreign body in the urethra and bladder. Implanted urinary catheters rapidly acquire a complex, three-dimensional biofilm composed of bacteria, their extracellular products, and components deposited from bodily fluids. The pathogenic organisms in a biofilm continually seed the bladder, leading to bacteriuria and/or UTI.2 Bacterial interference, or using benign bacteria to prevent infection with virulent pathogens,3, 4 may offer a solution to the significant problem of recurrent episodes of UTI in persons with indwelling catheters. Since biofilm formation on a wet implanted device such as a urinary catheter is nearly impossible to prevent,5, 6 we propose instead to manipulate the adherent microbial flora. We propose that inserting urinary catheters than have been pre-inoculated with a benign strain of Escherichia coli (83972) will be an efficient means to colonize the neurogenic bladder with this harmless organism. If successful colonization is achieved in this pilot trial, a larger clinical trial will be designed to test the efficacy of this approach to prevent bladder colonization by pathogenic organisms and thus to prevent UTI.

Interventions

  • DEVICE Insertion of a urinary catheter coated with benign E. coli

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2003-11
Est. Completion 2005-07
Phase Phase 1

What the Registry Record Tells You About NCT00458471

The ClinicalTrials.gov registry entry for NCT00458471 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Insertion of a urinary catheter coated with benign E. coli is the first listed.

NCT00458471 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00458471 about?

NCT00458471 is a clinical study titled "E. Coli for Prevention of Catheter UTI in SCI Patients". The overall goal of this project is to develop a new approach for the prevention of urinary tract infection (UTI) in persons who rely on indwelling catheters for bladder drainage. Veterans with spinal cord injury (SCI) frequently require chronic bladder catheterization. Most individuals with SCI hav...

What is the current status of trial NCT00458471?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2003-11. Estimated completion is 2005-07.

What interventions are being tested in trial NCT00458471?

The interventions under investigation include: Insertion of a urinary catheter coated with benign E. coli (DEVICE).

Who is sponsoring clinical trial NCT00458471?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.