Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284843
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2006-01-30
Brief Title:
Prevalence of RHD Pyoderma and Scabies in Children in Fiji
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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 Fiji
Status:
COMPLETED
Status Verified Date:
2007-10
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:
None
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 Description:
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 5200 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 these valves is identified or if another pathology is suspected the child will be referred to a pediatric cardiologist for full echocardiogram The primary endpoints of the study will be to determine the prevalence of echocardiogram confirmed rheumatic heart disease and to determine the prevalence of pyoderma assessed using a standardized tool The secondary endpoints will be to determine prevalence of scabies assessed using a standardized tool prerevalence of heart failure or signs of ventricular enlargement in children with echocardiographically-confirmed RHD distribution and severity of valvular lesions in children with echocardiographically-confirmed RHD prevalence of severe pyoderma and body distribution upper vs lower of lesions and prevalence of scabies severe scabies and body distribution upper vs lower of scabies lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None