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NCT03101371 · ClinicalTrials.gov registry record · Phase 2
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT03101371: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT03101371 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101371, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.
Primary Outcome
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as \>10\^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
Interventions
- DRUG Catheter insertion with Povidone Iodine
- PROCEDURE Standard of care catheter insertion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2019-02-15 |
| Phase | Phase 2 |
What the finished NCT03101371 record still lists
NCT03101371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Catheter insertion with Povidone Iodine is the first listed.
NCT03101371 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03101371 about?
NCT03101371 is a clinical study titled "Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion". Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complica...
What is the current status of trial NCT03101371?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2017-10-10. Estimated completion is 2019-02-15.
What interventions are being tested in trial NCT03101371?
The interventions under investigation include: Catheter insertion with Povidone Iodine (DRUG), Standard of care catheter insertion (PROCEDURE).
Who is sponsoring clinical trial NCT03101371?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03101371's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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