Rift Valley Fever in Kenya

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00287014
First received: February 2, 2006
Last updated: August 26, 2010
Last verified: October 2007
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00287014     History of Changes
Other Study ID Numbers: 05-0042
Study First Received: February 2, 2006
Last Updated: August 26, 2010
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Coccidioidomycosis
Coccidiosis
Fever
Rift Valley Fever
Mycoses
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Hepatitis, Viral, Animal
Bunyaviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Hepatitis, Animal
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014