GRoup A StrePtococcus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-09

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Streptococcal Pharyngitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Identifying group A strep carriers

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory DeMuri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Health Pediatric Clinics

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cherie Schommer, BA

Role: CONTACT

[email protected]

608-262-2631

Facility Contacts

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Bridget Johnson, BAN,RN,CCRC

Role: primary

[email protected]

608-264-1400

References

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

Reference Type BACKGROUND

PMID: 11172144 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16253886 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19729843 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 9745311 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19244387 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20459815 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20979621 (View on PubMed)