Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
Condition: S. Aureus Oropharyngeal Colonization
Intervention: Chlorhexidine gluconate; Saline Placebo
Intervention description: 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.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of skin or soft tissue infection that occurred between 1 month and 5 years
             ago, regardless of whether antibiotics were given, as per patient report

          2. Age > 5 years and < 18 years.

          3. Able to gargle as assessed by verbal question.

          4. Willing and able to undergo nares and oropharyngeal swabbing.

          5. Able to come to the research clinic for study follow-up visits for the study period.

        Exclusion Criteria:

          1. Current suspected or confirmed infection requiring systemic antibiotics.

          2. Receipt of systemic antibiotics in the prior 28 days.

          3. Plans for administration or likely receipt of systemic antibiotics in the next 28 days
             (e.g., if the patient suffers from recurrent infections such as otitis media or has a
             planned surgery that requires prophylactic antibiotics).

          4. Plans for hospitalization or likely hospitalization in the next 28 days (e.g., if the
             patient suffers from recurrent infections)

          5. Any of the following in the prior 6 months: hemodialysis, peritoneal dialysis, central
             venous catheter placement, and systemic chemotherapy for cancer, any
             immune-compromising condition.

          6. Previous participation in the study.

          7. Pregnancy (all female subjects of childbearing age will be given a pregnancy test
             prior to enrollment).