Prevalence of RHD, Pyoderma and Scabies in Children in Fiji
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.
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 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 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 Design
Time Perspective: Prospective
Conditions
Streptococcus Group A
Location
Colonial War Memorial Hospital
Suva
Fiji
Status
Completed
Source
National Institute of Allergy and Infectious Diseases (NIAID)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00284843
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Viridans Streptococci
A large heterogeneous group of mostly alpha-hemolytic streptococci. They colonize the respiratory tract at birth and generally have a low degree of pathogenicity. This group of species includes STREPTOCOCCUS MITIS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS ORALIS; STREPTOCOCCUS SANGUIS; STREPTOCOCCUS SOBRINUS; and the STREPTOCOCCUS MILLERI GROUP. The latter are often beta-hemolytic and commonly produce invasive pyogenic infections including brain and abdominal abscesses.
Streptococcus Anginosus
A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is the most frequently seen isolate of that group, has a proclivity for abscess formation, and is most often isolated from the blood, gastrointestinal, and urogenital tract.
Streptococcus Constellatus
A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is commonly found in the oropharnyx flora and has a proclivity for abscess formation in the upper body and respiratory tract.
Streptococcus Intermedius
A species of gram-positive bacteria in the STREPTOCOCCUS MILLERI GROUP. It is commonly found in the oropharynx flora and has a proclivity for abscess formation, most characteristically in the CENTRAL NERVOUS SYSTEM and LIVER.
Streptococcus Pyogenes
A species of gram-positive, coccoid bacteria isolated from skin lesions, blood, inflammatory exudates, and the upper respiratory tract of humans. It is a group A hemolytic Streptococcus that can cause SCARLET FEVER and RHEUMATIC FEVER.
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