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NCT01346774 · ClinicalTrials.gov registry record · Phase 2
Preventing Urinary Tract Infection Post-Surgery
A Phase 2 study of Urinary Tract Infection, sponsored by Betsy Foxman.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT01346774: Completed Phase 2 study of Urinary Tract Infection, sponsored by Betsy Foxman.
NCT01346774 is a Phase 2 study of Urinary Tract Infection that has completed, run by Betsy Foxman. The registered enrollment target is 200 participants, below the 655-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01346774, a Phase 2 study of Urinary Tract Infection, has completed, sponsored by Betsy Foxman.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. Cranberry products provide alternative means for preventing CAUTI and could result in decreased use of antimicrobials. In this pilot study we will enroll 200 women post gynecologic surgery and randomize them to take either cranberry powder capsules or placebo powder capsules. The low risk of harm associated with using cranberry to reduce UTI coupled with its potential benefit makes it a desirable intervention for the prevention of CAUTI. The conduct/ results of this pilot /feasibility study will prepare us for the conduct of a large scale clinical trial.
Primary Outcome
The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.
Conditions Studied
Interventions
- DRUG Cranberry powder capsules
- DRUG Placebo powder capsules
Study Locations (1)
Michigan
- Urogynecology Clinic; University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01346774 record still lists
NCT01346774 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 655-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Urinary Tract Infection appearing as the primary indexed condition, and to 2 interventions - of which Cranberry powder capsules is the first listed.
NCT01346774 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01346774 about?
NCT01346774 is a clinical study titled "Preventing Urinary Tract Infection Post-Surgery". Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery. Cranberry products provide alternative means for preventing CAUTI and ...
What is the current status of trial NCT01346774?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2011-06. Estimated completion is 2013-10.
What conditions does trial NCT01346774 study?
This clinical trial studies the following conditions: Urinary Tract Infection.
What interventions are being tested in trial NCT01346774?
The interventions under investigation include: Cranberry powder capsules (DRUG), Placebo powder capsules (DRUG).
Who is sponsoring clinical trial NCT01346774?
This trial is sponsored by Betsy Foxman, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01346774 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01346774's enrollment target sits among peer trials
200 9th of 11 higher than 2 of 11 other Urinary Tract Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Tract Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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