Malaria Incidence in Infants in Bancoumana, Mali

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00508417
First received: July 27, 2007
Last updated: February 12, 2011
Last verified: February 2011
  Purpose

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
Malaria Infection
Malaria Incidence
Anemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Malaria Incidence in Infants in Bancoumana, Mali

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 600
Study Start Date: July 2007
Estimated Study Completion Date: February 2011
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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 6 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508417

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

Publications:
ClinicalTrials.gov Identifier: NCT00508417     History of Changes
Other Study ID Numbers: 999907198, 07-I-N198
Study First Received: July 27, 2007
Last Updated: February 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Malaria Incidence
Anemia
Clinical Malaria

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections

ClinicalTrials.gov processed this record on October 21, 2014