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

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

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 Overview

• Status: Completed
• Conditions: S. Aureus Oropharyngeal Colonization
• Intervention / Treatment: Drug: Chlorhexidine gluconate; Drug: Saline Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Los Angeles BioMedical Research Institute (LA BioMed)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.	Drug: Chlorhexidine gluconate; 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.; Other Names: Peridex; Periogard
Placebo Comparator: Placebo; Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.	Drug: Saline Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Eradiction of S. Aureus From the Oropharyngeal at 7 Days	The primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model. .	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Eradication of S. Aureus Oropharyngeal Colonization at 28 Days	Secondary outcome is eradication of S. aureus oropharyngeal colonization at 28 days using an intention to treat (ITT) model.	28 days
Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days	We characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of the same strain at 28 days.	28 days
Number of Participants With Persistent Different Strain of S. Aureus Genetic Backgrounds at 28 Days	We characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of different strains at 28 days.	28 days

Collaborators and Investigators

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Loren G Miller, MD, MPH, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 30529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of trial results, data will be shared with investigators upon request to the Principal Investigator and after signing a Data Use Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP