Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307112
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2006-03-23
Brief Title:
Rheumatic Heart Disease Prevalence in Leon Nicaragua
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Study of the Prevalence of Rheumatic Heart Disease in Leon Nicaragua
Status:
COMPLETED
Status Verified Date:
2011-05
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:
A bacterium called Group A Steptoccoccus or strep is commonly found in the nose and throat of healthy adults and children and can cause a variety of illnesses If this bacterium infects another part of the body one or more times children may get Rheumatic heart disease RHD The purpose of this community based study is to see how many children between 5-15 years of age have RHD in Leon Nicaragua The study will also help to determine if the usual methods of detecting this disease are working Researchers hope that this study will help to develop vaccines that may prevent strep infections to Nicaragua and other parts of the world About 3600 children will take part in the study The children will participate for a minimum of 1 day and have a 6 month follow-up visit if they are identified as possible or probable RHD cases Study procedures will include clinical exams and echocardiograms to determine the presence of RHD
Detailed Description:
Group A streptococcal GrAS infections are responsible for a wide spectrum of clinical syndromes ranging from uncomplicated throat infections to life-threatening invasive infections Some cases of uncomplicated and untreated pharyngitis may trigger the onset of acute rheumatic fever ARF accompanied by rheumatic heart disease RHD ARF is the most common cause of heart disease in children around the world and is associated with early morbidity and mortality The most cost-effective method of preventing ARF and RHD would be vaccine prevention of the streptococcal infections that trigger the disease Unfortunately the overall burden of RHD in developing countries is unknown This information is needed to adequately assess the potential risk- and cost-benefits of a GrAS vaccine that may eventually be introduced in countries where ARF and RHD are prevalent The primary objective of this study is to determine the prevalence of RHD among children aged 5-15 in Leon The secondary objective is to determine the sensitivity and specificity of clinical examination of the heart in an area of suspected high prevalence of RHD Leon This is an uncontrolled observational community-based study designed to provide detailed information about the prevalence of RHD in children in León Nicaragua Children and adolescents between the ages of 5 and 15 will be eligible for enrollment Centro de Investigación en Demografía y Salud CIDS - Center for Investigation of Demography and Health staff will visit randomly selected dwellings with children between the target ages of 5 and 15 years explain the nature and purpose of the study and obtain signed informed consent from the parents or guardians of the children to collect demographic information The study will also be discussed with all children 13 years of age or older and their verbal agreement to participate in the study will be sought After informed consent has been obtained and children are enrolled CIDS staff will administer a questionnaire to capture the childrens demographics All enrolled children and their parents from a given area will be offered transportation to the rheumatic heart disease clinic at HEODRA by van CIDS staff will arrange the examinations and transportation and will inform the families appropriately All children whose parentsguardian provide informed consent will have at least one study visit at HEODRA On the day of the scheduled clinic visit the families will be informed again in detail about the RHD research study and written informed consent will again be obtained All children who participate in the study will have an auscultation and a screening echocardiogram as part of the study Those children who are identified by auscultation andor by echocardiography to be in the probable or possible rheumatic heart disease groups will be asked to return for repeat echocardiography 6 months after their first examination The primary and secondary endpoints of the study will be clinical diagnosis of RHD as confirmed by echocardiogram
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