Clinical Trial: Incidence of Group A Strep Pharyngitis in School Children in Fiji

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Epidemiology of Group A Streptococcal Infections in Fiji (Fiji GrASP) Part 3: The Incidence of Group A Streptococcal Pharyngitis and the Prevalence of Pyoderma and Sca

Brief Summary: The purpose of this study is to find out how often group A Streptococcus (GAS) occurs in school-age children of Central Fiji. This bacterium often causes pharyngitis (sore throat) and can also cause pyoderma (skin infection) or scabies. Approximately 1000 children ages 5-14 years will be enrolled from 4 primary schools in Central Fiji. These children will have throat swabs performed to determine how commonly GAS occurs. Over the next 10 months, children in this group who complain of sore throat will be examined and have throat swabs to determine if GAS is the cause. A subset of 600 children will be examined for pyoderma and scabies and have throat swabs every 2 months during the 10 month study. In addition, a small amount of blood will be drawn at 0, 6, and 10 months to determine the level of antibodies to Streptococcus.

Detailed Summary: This study is the third part of a series of 5 studies including DMID protocols 05-0081, 05-0082, 05-0118, and 06-0081. The primary objectives of this prospective cohort study are to estimate the incidence of group A streptococcal (GAS) pharyngitis in 1000 primary school aged school children in Fiji and to assess titers of anti-J8 antibodies and correlate titers of these antibodies against GAS infection in 600 primary school aged children in Fiji. Secondary objectives are to: estimate the point prevalence of GAS pyoderma in 600 primary school aged children in Fiji; estimate the point prevalence of scabies in 600 primary school aged children in Fiji; determine the pharyngeal carriage rate of group A streptococci in 1000 primary school aged children in Fiji; describe the clinical features of GAS pharyngitis in 1000 primary school aged children in Fiji; determine the upper limit of normal values for streptococcal serology (antistreptinolysin O and anti-DNase B); genotypically characterize group A streptococci isolated from throat swabs from primary school aged children with pharyngitis; genotypically characterize group A streptococci isolated from skin swabs from pyoderma lesions in school aged children in Fiji; and determine antimicrobial susceptibility to penicillin, clindamycin, erythromycin and chloramphenicol in 150 GAS isolates from skin swabs and 150 GAS isolates from throat swabs. Approximately 1000 school children aged 5 -14 from 4 primary schools will be enrolled in the study with approximately 600 of these 1000 school children aged 5-14 from 3 of the schools in the substudy. Children in the main study will participate for 1-2 days, and children in the substudy will participate for a 10-month period. All children at the start of the study will have swabs taken to determine the pharyngeal carriage rate of GAS. Over the next 10 months school children will be examined for pharyngitis when they complain of sore throat and throat swabs will be taken to prove GAS as
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: January 30, 2006
Date Started: January 2006
Date Completion: November 2006
Last Updated: January 24, 2008
Last Verified: October 2007