NCT00508417

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration 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

July 24, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2011

Completed
Last Updated

July 2, 2017

Status Verified

February 11, 2011

First QC Date

July 27, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Malaria IncidenceAnemiaClinical Malaria

Eligibility Criteria

Age6 Weeks - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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
  • Participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing
  • Infant born to mother with known or suspected HIV/AIDS as determined by the clinician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Duflo B, Balique H, Ranque P, Diallo AN, Brucker G, Alavi H, Prescott N. [Estimation of the impact of the principal diseases in rural Mali]. Rev Epidemiol Sante Publique. 1986;34(6):405-18. French.

    PMID: 3105007BACKGROUND
  • Wagner G, Koram K, McGuinness D, Bennett S, Nkrumah F, Riley E. High incidence of asymptomatic malara infections in a birth cohort of children less than one year of age in Ghana, detected by multicopy gene polymerase chain reaction. Am J Trop Med Hyg. 1998 Jul;59(1):115-23. doi: 10.4269/ajtmh.1998.59.115.

    PMID: 9684638BACKGROUND
  • Moody AH, Chiodini PL. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. Br J Biomed Sci. 2002;59(4):228-31. doi: 10.1080/09674845.2002.11783665.

    PMID: 12572958BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 30, 2007

Study Start

July 24, 2007

Study Completion

February 11, 2011

Last Updated

July 2, 2017

Record last verified: 2011-02-11

Locations