CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Chlorhexidine gluconate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02589067
NCT02589067Phase 2Completed

Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization.

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·interventional·Posted Oct 28, 2015·Updated Dec 29, 2020

In Brief

A Phase 2 clinical trial evaluating Chlorhexidine gluconate and Saline Placebo for S. Aureus Oropharyngeal Colonization. Completed, enrolled 67 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 28, 2015
Enrollment StartOct 1, 2015
Primary CompletionOct 1, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.7 years ago

Interventions

Chlorhexidine gluconatedrug

Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.

Saline Placebodrug

Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.