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Recruiting NCT01558804

GRoup A StrePtococcus

— Observational Streptococcal Pharyngitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Identifying group A strep carriers.
Who it may be relevant to
Registry conditions: Streptococcal Pharyngitis. Basic parameters: 5 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Identifying children who are pharyngeal carriers of Group A streptococcus [Time frame: 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • UW Health Pediatric Clinics — Madison

Publications

  • Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. doi: 10.1056/NEJM200101183440308. PMID 11172144
  • 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 16253886
  • 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 19729843
  • Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291. PMID 9745311
  • 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 19244387
  • 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 20459815
  • 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. PMID 20979621

Identifiers

NCT: NCT01558804 · 2015-1456 · 2011-0058 · A536700 · SMPH\PEDIATRICS\PEDIATRICS · 1R21AI147502-01 · Protocol Version 9/14/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗