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Recruiting

NCT Number: NCT01558804

GRoup A StrePtococcus

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.

Recruiting

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Health Pediatric Clinics

Madison, Wisconsin, 53717, United States

Location status: Recruiting

Location contact

Bridget Johnson, BAN,RN,CCRC

CONTACT

[email protected]

608-264-1400

Ellen R Wald, MD

SUB_INVESTIGATOR

Gregory DeMuri, MD

PRINCIPAL_INVESTIGATOR

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Identifying group A strep carriers

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.

Primary outcomes

  1. Identifying children who are pharyngeal carriers of Group A streptococcus

    Time frame: 2 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cherie Schommer, BA

CONTACT

[email protected]

608-262-2631

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: GRASP

Important dates

Study start
2011
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2012
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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