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

NCT ID: NCT02589067

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-11-30

Brief 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.

Conditions

S. Aureus Oropharyngeal Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days.

Group Type: EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type: DRUG

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

Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Peridex; Periogard

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loren G Miller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Locations

Los Angeles BioMedical Research Institute (LA BioMed)

Torrance, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

30529

Identifier Type: -

Identifier Source: org_study_id