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临床试验/NCT01558804
NCT01558804
招募中
不适用

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

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 180 人2011年5月9日

概览

阶段
不适用
干预措施
Identifying group A strep carriers
疾病 / 适应症
Streptococcal Pharyngitis
发起方
University of Wisconsin, Madison
入组人数
180
试验地点
1
主要终点
Identifying children who are pharyngeal carriers of Group A streptococcus
状态
招募中
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2011年5月9日
结束日期
2028年6月1日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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).

干预措施: Identifying group A strep carriers

结局指标

主要结局

Identifying children who are pharyngeal carriers of Group A streptococcus

时间窗: 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

研究点 (1)

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