Rift Valley FeverNCT00287014
Rift Valley Fever in Kenya
An observational study of Rift Valley Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Rift Valley Fever
- How many people
- 250 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2006to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
- Informed consent is obtained and signed, and assent form is obtained and signed from children age 7 and older,
- Subject has understanding of study procedures, and
- Subject is able to comply with study procedures for the entire length of the study.
Who cannot join
- Age less than 1 year.
- Subjects who immigrated to the study area less than 2 years previously.
- Acutely ill Ijara residents.
- Adults and children who cannot provide informed consent or who cannot participate fully in the study procedures will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey
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.
Read the 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.
- Conditions
- Rift Valley Fever
- Keywords
- Rift valley fever, Kenya
- Medical subject headings
- Rift Valley Fever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startMar 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rift Valley FeverStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 250 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287014
- Sponsor's protocol ID
- 05-0042
- Status last verified
- Oct 2007
- First submitted
- 2 Feb 2006
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Outcomes of Rift Valley Fever in Kenya: Ijara Clinical Survey
- ClinicalTrials.gov ID
- NCT00287014
- Acronym / sponsor ID
- 05-0042
- Conditions
- Rift Valley Fever
- Keywords
- Rift valley fever, Kenya
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2006
- Study completion
- Apr 2006
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- Informed consent is obtained and signed, and assent form is obtained and signed from children age 7 and older,
- Subject has understanding of study procedures, and
- Subject is able to comply with study procedures for the entire length of the study.
Key exclusion criteria (4 listed)
- Age less than 1 year.
- Subjects who immigrated to the study area less than 2 years previously.
- Acutely ill Ijara residents.
- Adults and children who cannot provide informed consent or who cannot participate fully in the study procedures will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
Related trials for Rift Valley Fever
RecruitingObservational study
RVF and Other Emerging Infectious Diseases in East and Central Africa
Rift Valley Fever, Hemorrhagic Fevers, Viral
Active, not recruitingPhase 1
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
Rift Valley Fever
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 2
Safety and Immunogenicity of a Candidate Rift Valley Fever Vaccine (RVF003)
Rift Valley Fever
RecruitingPhase 2
Phase 2 Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Rift Valley Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rift Valley Fever, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.