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

NCT02589067 | Completed Phase 2 Results DMC

• 1 other identifier: 30529
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

S. Aureus Oropharyngeal Colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants Eradication of S. Aureus Oropharyngeal Colonization at 28 Days

  28 days

• Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days

  28 days

• Number of Participants With Persistent Different Strain of S. Aureus Genetic Backgrounds at 28 Days

  28 days

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

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

Drug: Saline Placebo

Interventions

Chlorhexidine gluconate 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.

Also known as: Peridex, Periogard

Experimental

Saline Placebo 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.

Placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Age \> 5 years and \< 18 years.
• Able to gargle as assessed by verbal question.
• Willing and able to undergo nares and oropharyngeal swabbing.
• Able to come to the research clinic for study follow-up visits for the study period.

You may not qualify if:

• Current suspected or confirmed infection requiring systemic antibiotics.
• Receipt of systemic antibiotics in the prior 28 days.
• 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).
• Plans for hospitalization or likely hospitalization in the next 28 days (e.g., if the patient suffers from recurrent infections)
• 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.
• Previous participation in the study.
• Pregnancy (all female subjects of childbearing age will be given a pregnancy test prior to enrollment).

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Los Angeles BioMedical Research Institute (LA BioMed)

Torrance, California, 90502, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Loren G. Miller
• Organization: The Lundquist Institute at Harbor-UCLA

lmiller@lundquist.org

310-222-3775

Study Officials

• Loren G Miller, MD, MPH

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 29, 2020
• Results First Posted: December 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)