Rift Valley Fever in Kenya

Rift Valley Fever Clinical Trial

Official title:

Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287014
• Other study ID #: 05-0042
• Status: Completed
• Phase: N/A
• First received: February 2, 2006
• Last updated: August 26, 2010
• Start date: March 2006
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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 disease/infection 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 Kenya's next RVF epizootic/epidemic. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

Those adults and children residing in selected survey households in the area of Ijara Town and its 5 km environs who are 1 year of age and older will be eligible, provided:

1. Informed consent is obtained and signed, and assent form is obtained and signed from children age 7 and older,

2. Subject has understanding of study procedures, and

3. Subject is able to comply with study procedures for the entire length of the study.

Exclusion Criteria:

1. Age less than 1 year.

2. Subjects who immigrated to the study area less than 2 years previously.

3. Acutely ill Ijara residents.

4. Adults and children who cannot provide informed consent or who cannot participate fully in the study procedures will also be excluded.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Coccidioidomycosis
• Fever
• Rift Valley Fever

Locations

Country	Name	City	State
Kenya	Ijara District	Ijara

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Kenya,