Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rift Valley Fever in Kenya
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00287014
  Purpose

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.


Condition
Rift Valley Fever

MedlinePlus related topics: Fever
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 250
Study Start Date: March 2006
Estimated Study Completion Date: April 2006
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 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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287014

Locations
Kenya
Ijara District
Ijara, Kenya
Sponsors and Collaborators
  More Information

Study ID Numbers: 05-0042
Study First Received: February 2, 2006
Last Updated: January 24, 2008
ClinicalTrials.gov Identifier: NCT00287014  
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Rift valley fever, Kenya

Study placed in the following topic categories:
Liver Diseases
Fever
Virus Diseases
Hepatitis
Signs and Symptoms
Mycoses
Rift Valley Fever
Hemorrhagic Fevers, Viral
Digestive System Diseases
Coccidioidomycosis
Hemorrhagic fever
Viral hemorrhagic fever
Arbovirus Infections

Additional relevant MeSH terms:
RNA Virus Infections
Hepatitis, Viral, Animal
Bunyaviridae Infections
Hepatitis, Animal
Body Temperature Changes

ClinicalTrials.gov processed this record on January 16, 2009