Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
Public ClinicalTrials.gov record NCT02589067. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02589067
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 67 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2015
- Primary completion
- Sep 30, 2017
- Completion
- Oct 31, 2017
- Last update posted
- Dec 28, 2020
2015 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles BioMedical Research Institute (LA BioMed) | Torrance | California | 90502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02589067, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 28, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02589067 live on ClinicalTrials.gov.