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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-0058 | Other Identifier | IRB number - replaced | |
| A536700 | Other Identifier | UW Madison | |
| SMPH\PEDIATRICS\PEDIATRICS | Other Identifier | UW Madison | |
| 1R21AI147502-01 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 9/14/2023 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
The overall objective of this investigation is to understand the differences in Group A streptococci in children who are acutely infected from those who are carriers. The hypothesis is that when in the carrier state, GAS exhibits unique transcriptional profiles that differ from those of the acute infection state. The investigators expect transcriptional profiles of GAS to provide important information regarding the changes the organism undergoes when transitioning between acute infection and carriage.
The specific aims of this study are:
To do this, the investigators will to identify 12 children with acute pharyngitis due to Group A streptococcus (GAS) 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 8-10% of these children with pharyngitis and a positive culture or rapid antigen detection test (RADT) for GAS will be carriers. Therefore,180 participants will need to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Strep Positive | Children will be eligible for this study if they are ages 5 to 15 years and have been diagnosed to have acute pharyngitis caused by GAS with a positive Rapid Antigen Detection Test (RADT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Identifying group A strep carriers | Other | At study entry, at 14 days, and if follow up is positive, again in 14-21 days: Standard culture for GAS and analysis of mRNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identifying children who are pharyngeal carriers of Group A streptococcus | 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 | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Children will be eligible for this study if they are ages 5 to 15 years and have been diagnosed to have acute pharyngitis caused by GAS (with a positive rapid antigen detection test (RADT). Children will be excluded if they are unable to take beta lactam antibiotics. Children will be enrolled at UW Health sites in Madison, Wisconsin, including both pediatric ambulatory care clinics and urgent care clinics. The study team will offer participants the option to complete follow-up study visits in-clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cherie Schommer, BA | Contact | 608-262-2631 | schommer2@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory DeMuri, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health Pediatric Clinics | Recruiting | Madison | Wisconsin | 53717 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11172144 | Background | Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. doi: 10.1056/NEJM200101183440308. | |
| 16253886 | Background | Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X. | |
| Label | URL |
|---|---|
| University of Wisconsin-Madison Department of Pediatrics Research Information | View source |
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Throat swab specimens
| 19729843 |
| Background |
| Musser JM, Shelburne SA 3rd. A decade of molecular pathogenomic analysis of group A Streptococcus. J Clin Invest. 2009 Sep;119(9):2455-63. doi: 10.1172/JCI38095. |
| 9745311 | Background | Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291. |
| 19244387 | Background | Jiang H, Wong WH. Statistical inferences for isoform expression in RNA-Seq. Bioinformatics. 2009 Apr 15;25(8):1026-32. doi: 10.1093/bioinformatics/btp113. Epub 2009 Feb 25. |
| 20459815 | Background | Li J, Jiang H, Wong WH. Modeling non-uniformity in short-read rates in RNA-Seq data. Genome Biol. 2010;11(5):R50. doi: 10.1186/gb-2010-11-5-r50. Epub 2010 May 11. |
| 20979621 | Background | Anders S, Huber W. Differential expression analysis for sequence count data. Genome Biol. 2010;11(10):R106. doi: 10.1186/gb-2010-11-10-r106. Epub 2010 Oct 27. |