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Malaria Incidence in Infants in Bancoumana, Mali

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00508417
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:

This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines.

Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests.

Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.


Condition or disease
Malaria Infection Malaria Incidence Anemia

Detailed Description:
This is an observational study to determine the burden of malaria in rural Malian infants. Infants will be identified during a village-wide census and at Expanded Program for Immunization (EPI) visits. After obtaining community consent, eligible infants' parents will be invited to bring infants to the clinic for screening. Enrolled infants will receive a baseline evaluation and monthly visits during the rainy season at which times they will receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, malaria antibody titers (at first and last visit for each transmission season), and hemoglobin typing at one visit. Study subjects will also receive a weekly home visit to determine if they are well or ill. If ill or febrile at any visit, or if they present to the clinic for an unscheduled visit, subjects will receive a history and physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, filter paper blood collection and an RDT for malaria. Diagnosis and treatment of malaria will be performed according to Mali National Malaria Control Program (NMCP) guidelines. Diagnosis and treatment of other conditions will be performed as determined by the treating clinician.

Study Design

Study Type : Observational
Estimated Enrollment : 600 participants
Time Perspective: Prospective
Official Title: Malaria Incidence in Infants in Bancoumana, Mali
Study Start Date : July 24, 2007
Estimated Study Completion Date : February 11, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Infants at least six weeks to less than 7 months of age at enrollment
    2. Known residents of the Bancoumana health area
    3. Good general health as determined by clinical exam
    4. Available for the 6-7 months duration of the trial
    5. Willingness to participate as evidenced by signing of the informed consent or fingerprinting by the parent or guardian

EXCLUSION CRITERIA:

  1. Social, behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol
  2. Participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing
  3. Infant born to mother with known or suspected HIV/AIDS as determined by the clinician
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508417


Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)