Clinical trial NCT01558804: GRoup A StrePtococcus
Official title: Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Streptococcal Pharyngitis
Keywords: Streptococcus pyogenes
Streptococcus
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2012-03-20
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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.

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

Primary outcomes:
measure: Identifying children who are pharyngeal carriers of Group A streptococcus
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Pediatric Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Gregory DeMuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291.
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.
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.
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.