Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01558804
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GRoup A StrePtococcus
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Gene Expression in Isolates of Group A Streptococci Recovered From Patients Who Are Carriers
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRASP
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.
Detailed Description:
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:
1. 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.
2. 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.
The specific aims of this study are:
1. 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.
2. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: