Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center