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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01349192
The ClinicalTrials.gov registry entry for NCT01349192 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Rifampin is the first listed.
NCT01349192 reports 0 study locations.
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.
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