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GRoup A StrePtococcus (GRASP)

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ClinicalTrials.gov Identifier: NCT01558804
Recruitment Status : Recruiting
First Posted : March 20, 2012
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Streptococcal Pharyngitis Other: Identifying group A strep carriers

Detailed 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.


Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers
Study Start Date : November 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Other: Identifying group A strep carriers
At study entry and at 14 days: Standard culture for GAS and analysis of mRNA.


Outcome Measures

Primary Outcome Measures :
  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



Biospecimen Retention:   Samples With DNA
Throat swab specimens

Eligibility Criteria

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558804


Contacts
Contact: Cherie Schommer, BA 608-262-2631 schommer2@wisc.edu

Locations
United States, Wisconsin
UW Pediatrics at 20 S. Park St Recruiting
Madison, Wisconsin, United States, 53716
Contact: Stacey Moyer, MSN    608-262-9531    scmoyer@wisc.edu   
Principal Investigator: Gregory Demuri, MD         
Sub-Investigator: Ellen Wald, MD         
UW Health West Towne Pediatrics Recruiting
Madison, Wisconsin, United States, 53717
Contact: Stacey Moyer, MSN    608-262-9531    scmoyer@wisc.edu   
Principal Investigator: Gregory DeMuri, MD         
Sub-Investigator: Ellen R Wald, MD         
University of Wisconsin Hospital and Clinics (UWHC) Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Ellen Wald, MD         
Sub-Investigator: Michael Kim, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Gregory DeMuri, MD University of Wisconsin, Madison
More Information

Additional Information:
Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01558804     History of Changes
Other Study ID Numbers: 2011-0058
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:
Streptococcus pyogenes
Streptococcus

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases