Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01558804
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GRoup A StrePtococcus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Throat swab specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identifying children who are pharyngeal carriers of Group A streptococcus', 'timeFrame': '2 weeks', 'description': '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.\n\nThirty 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Streptococcus pyogenes', 'Streptococcus'], 'conditions': ['Streptococcal Pharyngitis']}, 'referencesModule': {'references': [{'pmid': '11172144', 'type': 'BACKGROUND', 'citation': 'Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. doi: 10.1056/NEJM200101183440308.'}, {'pmid': '16253886', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19729843', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9745311', 'type': 'BACKGROUND', 'citation': 'Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291.'}, {'pmid': '19244387', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20459815', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20979621', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.pediatrics.wisc.edu/research/', 'label': 'University of Wisconsin-Madison Department of Pediatrics Research Information'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe specific aims of this study are:\n\n1. To collect longitudinal participant-samples from acute and carriage phases of GAS infection and compare transcriptomic profiles and whole genome sequences of GAS recovered from acute and carrier pharyngeal swabs obtained from the same participants.\n2. To evaluate how identified differentially expressed genes, or observed genetic polymorphisms, influence GAS models of bacterial colonization and pathogenesis.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 5-15 years\n* Positive rapid antigen detection test for group A streptococcus\n* Parent or legal guardian present and able to provide consent\n* Provider prescribes treatment with a beta lactam antibiotic\n* English speaking\n\nExclusion Criteria:\n\n* Unable to take beta lactam antibiotics\n* Other concurrent bacterial infection, i.e., pneumonia'}, 'identificationModule': {'nctId': 'NCT01558804', 'acronym': 'GRASP', 'briefTitle': 'GRoup A StrePtococcus', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers', 'orgStudyIdInfo': {'id': '2011-0058'}, 'secondaryIdInfos': [{'id': '2015-1456', 'type': 'OTHER', 'domain': 'Institutional Review Board - 5 year replacement'}, {'id': 'A536700', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\PEDIATRICS\\PEDIATRICS', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R21AI147502-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AI147502-01', 'type': 'NIH'}, {'id': 'Protocol Version 9/14/2023', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rapid Strep Positive', 'description': '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).', 'interventionNames': ['Other: Identifying group A strep carriers']}], 'interventions': [{'name': 'Identifying group A strep carriers', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Rapid Strep Positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53717', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bridget Johnson, BAN,RN,CCRC', 'role': 'CONTACT', 'email': 'bridget.johnson@pediatrics.wisc.edu', 'phone': '608-264-1400'}, {'name': 'Gregory DeMuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ellen R Wald, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UW Health Pediatric Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Cherie Schommer, BA', 'role': 'CONTACT', 'email': 'schommer2@wisc.edu', 'phone': '608-262-2631'}], 'overallOfficials': [{'name': 'Gregory DeMuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}