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NCT02589067 · ClinicalTrials.gov registry record · Phase 2
Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
A Phase 2 study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT02589067 is a Phase 2 study that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 67 participants.
The verdict
NCT02589067, a Phase 2 study, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.
Interventions
- DRUG Saline Placebo
- DRUG Chlorhexidine gluconate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02589067
The ClinicalTrials.gov registry entry for NCT02589067 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline Placebo is the first listed.
NCT02589067 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02589067 about?
NCT02589067 is a clinical study titled "Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization". The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. This problem will be studied through a randomized, dou...
What is the current status of trial NCT02589067?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2015-10. Estimated completion is 2017-11.
What interventions are being tested in trial NCT02589067?
The interventions under investigation include: Saline Placebo (DRUG), Chlorhexidine gluconate (DRUG).
Who is sponsoring clinical trial NCT02589067?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
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