NCT00393757

Brief Summary

The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A better understanding of factors contributing to malaria may be necessary for malaria vaccine planning. These factors include interactions between age, where malaria is passed from mosquitoes to people, immune system (how the body fights infection) responses and other factors that contribute to malaria in epidemic-prone areas. About 6400 people from the villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home surveys, which will involve a census and an interview by researchers. Blood samples and smears will be collected from some volunteers in both communities to understand how the body protects itself from malaria and to check for malaria parasites. Twice each month, random houses will be selected from 3 places in the village to measure the number of mosquitoes in the home. Participants may be involved in the study for up to 4 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2011

Completed
Last Updated

February 1, 2019

Status Verified

October 1, 2007

Enrollment Period

4.3 years

First QC Date

October 26, 2006

Last Update Submit

January 30, 2019

Conditions

Keywords

Malaria, Plasmodium falciparum, Kenya

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Active surveillance of clinical malaria -Individuals of any age who live in the area (Kipsamoite or Kapsisiywa) for more than 6 months of the year, or, if they are new to the area, who plan to live in the area for more than 6 months of the year (permanent residents).
  • Passive surveillance of clinical malaria
  • Any individual living within the boundaries of the 2 study areas (Kipsamoite and Kapsisiywa)

You may not qualify if:

  • Active surveillance of clinical malaria
  • Declining to participate in the study
  • Will be gone from site more than 1 week per month
  • Not available for weekly symptom check or bimonthly blood sample collection
  • Passive surveillance of clinical malaria
  • Declining to participate in the study
  • Participation in active surveillance study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya Medical Research Institute

Kisumu, 40100, Kenya

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

October 1, 2006

Primary Completion

January 31, 2011

Study Completion

January 31, 2011

Last Updated

February 1, 2019

Record last verified: 2007-10

Locations