GRoup A StrePtococcus (GRASP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01558804
First received: March 8, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Streptococcal Pharyngitis
Other: Identifying group A strep carriers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Identifying children who are pharyngeal carriers of Group A streptococcus [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558804

Contacts
Contact: Stacey Moyer, MSN 608-262-9531 scmoyer@wisc.edu

Locations
United States, Wisconsin
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         
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         
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
Study First Received: March 8, 2012
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014