GRASP: GRoup A StrePtococcus

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01558804
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 180
• Locations: 4
• Anticipated Duration (Months): 145.7
• Patients Per Site: 45
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Streptococcal Pharyngitis	Other: Identifying group A strep carriers

Detailed Description

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:

1. 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.

2. To evaluate how identified differentially expressed genes, or observed genetic polymorphisms, influence GAS models of bacterial colonization and pathogenesis.

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers
• Actual Study Start Date: May 9, 2011
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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) and have not been treated with antibiotics in the last 30 days.	Other: Identifying group A strep carriers; 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.

Outcome Measures

Primary Outcome Measures

1. Identifying children who are pharyngeal carriers of Group A streptococcus [2 weeks]

   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 Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children ages 5-15 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

Locations

	Site	City	State	Country	Postal Code
1	UW Pediatrics at 20 S. Park St	Madison	Wisconsin	United States	53716
2	UW Health West Towne Pediatrics	Madison	Wisconsin	United States	53717
3	UW West Towne Urgent Care and Pediatric After Hours Clinic	Madison	Wisconsin	United States	53717
4	University of Wisconsin Hospital and Clinics (UWHC)	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Gregory DeMuri, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Wisconsin-Madison Department of Pediatrics Research Information

Publications

• 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.
• Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. Review.
• 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. Review.
• 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.
• 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.
• 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. Review.
• Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. Review.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01558804
• Other Study ID Numbers: 2011-0058; 2015-1456; A536700; SMPH\PEDIATRICS\PEDIATRICS; 1R21AI147502-01
• First Posted: Mar 20, 2012
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: Streptococcus pyogenes; Streptococcus
• Additional relevant MeSH terms: Pharyngitis

Study Results

No Results Posted as of Apr 19, 2022