GRoup A StrePtococcus

Streptococcal Pharyngitis Clinical Trial

— GRASP  

Official title:

Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01558804
• Other study ID #: 2011-0058
• Secondary ID: 2015-1456A536700
• Status: Recruiting
• Start date: May 9, 2011
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Cherie Schommer, BA
• Phone: 608-262-2631
• Email: schommer2[@]wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children ages 5-15 years

• Positive rapid antigen detection test for group A streptococcus

• Parent or legal guardian present and able to provide consent

• Provider prescribes treatment with a beta lactam antibiotic

• English speaking

Exclusion Criteria:

• Unable to take beta lactam antibiotics

• Other concurrent bacterial infection, i.e., pneumonia

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Pharyngitis

Intervention

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.

Locations

Country	Name	City	State
United States	UW Health Pediatric Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. doi: 10.1056/NEJM200101183440308. — View 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. — View 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. — View 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. — View 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. — View Citation

Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   University of Wisconsin-Madison Department of Pediatrics Research Information