Official Title: “Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers”
The purpose of the research is to help understand why some children become carriers of strep and whether children who are carriers need to be treated with antibiotics.
- Study Type: Observational
- Study Design: Observational Model: Cohort, Time Perspective: Prospective
- Study Primary Completion Date: June 2016
Detailed Clinical Trial Description
The objective of this investigation is to develop a method to distinguish children who are acutely infected with GAS from those who are carriers. If the carrier state can be differentiated from acute infection we will be able to avoid unnecessary treatment of children with pharyngitis or other respiratory symptoms from whom GAS are recovered but who are not truly infected with GAS. This will facilitate the primary prevention of acute rheumatic fever globally without enhancing antimicrobial resistance. The specific aim of this study is to identify 30 children with acute pharyngitis due to Group A streptococcus (GAS) and 30 children who are pharyngeal carriers of GAS.
Thirty percent of children 4 to 16 years of age with acute pharyngitis occurring between October and May will have a positive culture or rapid antigen detection test for GAS. Approximately 10-15% of these children with pharyngitis and a positive culture or rapid antigen detection test (RADT) for GAS will be carriers.
Interventions Used in this Clinical Trial
- Other: Identifying group A strep carriers
- At study entry and at 14 days: Standard culture for GAS and analysis of mRNA.
Arms, Groups and Cohorts in this Clinical Trial
- Rapid Strep Positive
- Children will be eligible for this study if they are ages 4 to 16 years and have been diagnosed to have acute pharyngitis caused by GAS (with a positive rapid antigen detection test (RADT) and have not been treated with antibiotics in the last 30 days. Children will be excluded if they are allergic to beta lactam antibiotics. Children will be enrolled at either one of two large pediatric practices in Madison, Wisconsin (20 S. Park St or West Clinic) or at the Pediatric Afterhours Clinic at University Station. They will present with acute symptoms of sore throat and fever. A RADT will be used for diagnosis.
Outcome Measures for this Clinical Trial
- Identifying children who are pharyngeal carriers of Group A streptococcus
- Time Frame: 2 weeks
Safety Issue?: No
- Time Frame: 2 weeks
Criteria for Participation in this Clinical Trial
- Children ages 4-16 years
- Positive rapid antigen detection test for group A streptococcus
- English speaking
- Treatment with antibiotics in the last 30 days.
- Allergic to beta lactam antibiotics.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 4 Years
Maximum Age for this Clinical Trial: 16 Years
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- University of Wisconsin, Madison
- Provider of Information About this Clinical Study
- Overall Official(s)
- Gregory DeMuri, MD, Principal Investigator, University of Wisconsin, Madison
- Overall Contact(s)
- Stacey Moyer, MSN, 608-262-9531, email@example.com
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