Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 5 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | October 2016 |
| Contact: | Loren G Miller, MD, MPH |
| Email: | lgmiller@ucla.edu |
| Phone: | 310-222-5623 |
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.
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.
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.
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.
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).
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