GRoup A StrePtococcus

Brief Summary

Official Title: “Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: June 2014

Detailed Clinical Trial Description

The objective of this investigation is to develop a method to distinguish children who are acutely infected with GAS from those who are carriers. If the carrier state can be differentiated from acute infection we will be able to avoid unnecessary treatment of children with pharyngitis or other respiratory symptoms from whom GAS are recovered but who are not truly infected with GAS. This will facilitate the primary prevention of acute rheumatic fever globally without enhancing antimicrobial resistance. 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.

Interventions Used in this Clinical Trial

  • Other: Identifying group A strep carriers
    • At study entry and at 14 days: Standard culture for GAS and analysis of mRNA.

Arms, Groups and Cohorts in this Clinical Trial

  • Rapid Strep Positive
    • Children will be eligible for this study if they are ages 4 to 16 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. Children will be excluded if they are allergic to beta lactam antibiotics. Children will be enrolled at either one of two large pediatric practices in Madison, Wisconsin (20 S. Park St or West Clinic) or at the Pediatric Afterhours Clinic at University Station. They will present with acute symptoms of sore throat and fever. A RADT will be used for diagnosis.

Outcome Measures for this Clinical Trial

Primary Measures

  • Identifying children who are pharyngeal carriers of Group A streptococcus
    • Time Frame: 2 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Children ages 4-16 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gregory DeMuri, MD, Principal Investigator, University of Wisconsin, Madison
  • Overall Contact(s)
    • Stacey Moyer, MSN, 608-262-9531, scmoyer@wisc.edu

References

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. PubMed 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. Review.

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

Jiang H, Wong WH. Statistical inferences for isoform expression in RNA-Seq. Bioinformatics. 2009 Apr 15;25(8):1026-32. 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.

Anders S, Huber W. Differential expression analysis for sequence count data. Genome Biol. 2010;11(10):R106. Epub 2010 Oct 27.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01558804