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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: Completed Phase 2 study, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model. .
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 |
What the finished NCT02589067 record still lists
NCT02589067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline Placebo is the first listed.
NCT02589067 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02589067's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 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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