Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
Condition: S. Aureus Oropharyngeal Colonization
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Each year, children visit doctors offices and emergency rooms over 2 million times due to
      skin and soft tissue infections (SSTIs). These SSTIs are usually caused by a bacteria called
      Staphylococcus aureus (S. aureus), and can result in severe negative consequences such as
      hospitalization, disability, and even death. Despite treatment with antibiotics, 20-70% of
      children with an SSTI will develop a recurrent infection within the next year. Additionally,
      this treatment fails to eradicate S. aureus from children nearly 50% of the time. Of the
      types of S. aureus that cause these infections, antibiotic-resistant strains such as
      methicillin-resistant S. aureus (MRSA), which are associated with higher rates of
      transmission, have become increasingly more common. Thus, 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.
    

Intervention name(s): Chlorhexidine gluconate; Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Peridex; Periogard
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention