Streptococcus Group ANCT00284843
Prevalence of RHD, Pyoderma and Scabies in Children in Fiji
An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Fiji.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Group A
- How many people
- 5,200 participants
- Where
- 1 siteFiji
- Study dates
- Jan 2006to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children between the ages of 5 to 14 years of age within the schools identified will be eligible to participate in the study and provide informed consent.
Who cannot join
- None identified
Trial locations and contacts
1 site in 1 country.
Fiji1 site
Colonial War Memorial Hospital
Suva
About this study
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
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.
Read the 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 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.
- Conditions
- Streptococcus Group A
- Keywords
- Streptococcus, Fiji, pyoderma, scabies, rheumatic disease
- Medical subject headings
- Pyoderma, Scabies, Rheumatic Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Group AStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284843
- Sponsor's protocol ID
- 05-0118
- Status last verified
- Oct 2007
- First submitted
- 30 Jan 2006
- Last updated
- 25 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00284843
- Acronym / sponsor ID
- 05-0118
- Conditions
- Streptococcus Group A
- Keywords
- Streptococcus, Fiji, pyoderma, scabies, rheumatic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,200 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2006
- Study completion
- Jun 2007
- First posted
- 1 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between the ages of 5 to 14 years of age within the schools identified will be eligible to participate in the study and provide informed consent.
Key exclusion criteria (1 listed)
- None identified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Group A, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Fiji.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Fiji. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008.