Clinical Trial: Prevalence of RHD, Pyoderma and Scabies in 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 1: The Prevalence of Rheumatic Heart Disease, Pyoderma and Scabies in School Children in Fij

Brief Summary: The purpose of this study is to estimate the number of cases of rheumatic heart disease, pyoderma, and scabies in school age children in Fiji. In addition the study will describe the features of rheumatic heart disease, pyoderma, and scabies in these children. Study participants will include 5200 primary school children, ages 5-14, from 21 primary schools in the Central Division of Fiji. These children will be examined for pyoderma, scabies, and the doctor will listen to their heart with a stethoscope. Any child that has a heart murmur detected will have their heart looked at through an echocardiogram test (uses sound waves to create a picture of how the heart is working). Any child that is found to have rheumatic heart disease will be referred to a pediatric cardiologist for further evaluation. Participants will be involved in the study for about 2 days.

Detailed Summary: This study is the first of 5 studies (including DMID protocols 05-0081, 05-0082, 05-0117, and 06-0081) in a larger project aimed at evaluating the epidemiology of infections caused by the group A streptococcus (GAS) in Fiji - this larger project is called the Fiji Group A Streptococcal Project (Fiji GrASP). Fiji GrASP is in turn part of a larger program aimed at progression of a novel GAS vaccine - this program is the project entitled "Global GAS Vaccine Based On The M-Protein". The three broad aims of the Fiji GrASP epidemiologic studies are to: establish the burden of disease of GAS infections in Fiji; describe the molecular epidemiology of GAS isolates in Fiji; and establish natural immunologic correlates of protection of a J8 vaccine if they exist. The Fiji GrASP epidemiologic studies are important for vaccine clinical trials in that they will gain a clear picture of the burden of GAS disease, develop ongoing surveillance and clinical endpoints for vaccine trials, collect isolates of GAS in Fiji, investigate immune correlates of vaccine protection, and prepare the existing clinical trial site for trials of the J-8 based vaccine. The primary objectives of this study are to estimate the prevalence of rheumatic heart disease (RHD) in primary school aged children in Fiji and to estimate the prevalence of pyoderma in these children. Secondary objectives are to: estimate the prevalence of scabies in primary school aged children in Fiji; describe the clinical and echocardiographic features of RHD in these children; and describe the clinical features of pyoderma and scabies in these children. Approximately 5,200 primary school children, 5-14 years of age, from 21 primary schools in the Central Division of Fiji will participate in this study. They will be examined for pyoderma and scabies, and they will have a standard auscultation by a pediatrician. Any child with a murmur will have a screening echocardiogram of the mitral and aortic valves. If abnormality of
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: June 2007
Last Updated: January 24, 2008
Last Verified: October 2007