GRoup A StrePtococcus (GRASP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Streptococcal Pharyngitis |
Other: Identifying group A strep carriers |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers |
- Identifying children who are pharyngeal carriers of Group A streptococcus [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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
Biospecimen Retention: Samples With DNA
Throat swab specimens
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Other: Identifying group A strep carriers
At study entry and at 14 days: Standard culture for GAS and analysis of mRNA.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Children ages 4-16 years
- Positive rapid antigen detection test for group A streptococcus
- English speaking
Exclusion Criteria:
- Treatment with antibiotics in the last 30 days.
- Allergic to beta lactam antibiotics.
Contacts and Locations| Contact: Stacey Moyer, MSN | 608-262-9531 | scmoyer@wisc.edu |
| United States, Wisconsin | |
| UW Health West Towne Pediatrics | Recruiting |
| Madison, Wisconsin, United States, 53717 | |
| Contact: Stacey Moyer, MSN 608-262-9531 scmoyer@wisc.edu | |
| Principal Investigator: Gregory DeMuri, MD | |
| Sub-Investigator: Ellen R Wald, MD | |
| UW Pediatrics at 20 S. Park St | Recruiting |
| Madison, Wisconsin, United States, 53716 | |
| Contact: Stacey Moyer, MSN 608-262-9531 scmoyer@wisc.edu | |
| Principal Investigator: Gregory Demuri, MD | |
| Sub-Investigator: Ellen Wald, MD | |
| University of Wisconsin Hospital and Clinics (UWHC) | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: Ellen Wald, MD | |
| Sub-Investigator: Michael Kim, MD | |
| Principal Investigator: | Gregory DeMuri, MD | University of Wisconsin, Madison |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01558804 History of Changes |
| Other Study ID Numbers: | 2011-0058 |
| Study First Received: | March 8, 2012 |
| Last Updated: | June 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Streptococcus pyogenes Streptococcus |
Additional relevant MeSH terms:
|
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013