Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287014
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2006-02-02
Brief Title:
Rift Valley Fever in Kenya
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Late Outcomes of Rift Valley Fever in Kenya Ijara Clinical Survey
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 find out how why and when Rift Valley Fever RVF spreads Participants will be 250 adults and children aged 1 year and older from the Ijara District Kenya They will be given a questionnaire undergo a medical examination that includes an eye exam and have a 1-teaspoon sample of blood taken from a vein Participation will take about 3 hours
Detailed Description:
The objective of this research is to better define the extent and timing of Rift Valley Fever RVF virus transmission and its related chronic diseaseinfection attack rate during an interepidemic period in a high-risk region that has seen repeated RVF outbreaks The results will be used to develop and refine predictive algorithms for RVF Virus transmission based on epidemiological environmental and remote sensing data with the ultimate goal of providing improved early detection of significant RVF outbreaks It is expected that the analysis of test-performance characteristics will determine the best use of serologic assays in Kenyas next RVF epizooticepidemic The primary outcome measure will be the current RVF-specific seropositivity profile for a cross-sectional survey population in Ijara District in northeast Kenya The secondary outcome measures to be studied will be 1 an assessment of the behavioral factors associated with risk of seropositivity previous infection in the study population and 2 the association of selected long-term ophthalmological and clinical outcomes with seropositivity The study design for this protocol involves questionnaire administration to consenting participants of Ijara District followed by performance of medical exams ophthalmologic exams and phlebotomy on all participants ELISA testing for RVF will then be performed on the blood samples obtained and all ELISA screen-positive samples will have confirmatory testing by plaque-reduction neutralizing antibody testing
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