NCT01558804

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2011Jun 2028

Study Start

First participant enrolled

May 9, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

17.1 years

First QC Date

March 8, 2012

Last Update Submit

February 13, 2026

Conditions

Streptococcal Pharyngitis

Keywords

Streptococcus pyogenesStreptococcus

Outcome Measures

Primary Outcomes (1)

  • Identifying children who are pharyngeal carriers of Group A streptococcus

    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

    2 weeks

Study Arms (1)

Rapid Strep Positive

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).

Other: Identifying group A strep carriers

Interventions

Identifying group A strep carriersOTHER

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.

Rapid Strep Positive

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Unable to take beta lactam antibiotics
  • Other concurrent bacterial infection, i.e., pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Health Pediatric Clinics

Madison, Wisconsin, 53717, United States

RECRUITING

Related Publications (7)

  • Bisno AL. Acute pharyngitis. N Engl J Med. 2001 Jan 18;344(3):205-11. doi: 10.1056/NEJM200101183440308.

    PMID: 11172144BACKGROUND

  • 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. doi: 10.1016/S1473-3099(05)70267-X.

    PMID: 16253886BACKGROUND

  • 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.

    PMID: 19729843BACKGROUND

  • Pichichero ME. Group A beta-hemolytic streptococcal infections. Pediatr Rev. 1998 Sep;19(9):291-302. doi: 10.1542/pir.19-9-291.

    PMID: 9745311BACKGROUND

  • 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.

    PMID: 19244387BACKGROUND

  • 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.

    PMID: 20459815BACKGROUND

  • 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.

    PMID: 20979621BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Throat swab specimens

Study Officials

  • Gregory DeMuri, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherie Schommer, BA

CONTACT

608-262-2631schommer2@wisc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 20, 2012

Study Start

May 9, 2011

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)