Malaria Incidence in Infants in Bancoumana, Mali

June 30, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 24, 2007

Study Completion

February 11, 2011

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimate)

July 30, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

February 11, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999907198
  • 07-I-N198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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