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NCT01349192 · ClinicalTrials.gov registry record · Phase 2
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01349192: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT01349192 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349192, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA. Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit. Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.
Primary Outcome
Proportion of subjects with a negative culture for MRSA at Day 28.
Interventions
- DRUG Rifampin
- DRUG Minocycline
- DRUG Mupirocin
- DRUG Trimethoprim/Sulfamethoxazole
- DRUG chlorhexidine gluconate oral rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
Why NCT01349192 stopped before completion
NCT01349192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.
NCT01349192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349192 about?
NCT01349192 is a clinical study titled "Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)". Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not...
What is the current status of trial NCT01349192?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2011-04. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01349192?
The interventions under investigation include: Rifampin (DRUG), Minocycline (DRUG), Mupirocin (DRUG), Trimethoprim/Sulfamethoxazole (DRUG), chlorhexidine gluconate oral rinse (DRUG).
Who is sponsoring clinical trial NCT01349192?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01349192's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 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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