Understanding malaria infection and disease in pregnant women and young children in Mali

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the immunologic and parasitologic factors that influence susceptibility to malaria infection and disease during pregnancy and early childhood in Mali. It will enroll up to 2000 pregnant women and their infants, as well as 2000 children aged 0-3 years, and follow them until they are 5 years old. The study will also include up to 3000 febrile hospitalized and non-hospitalized children up to age 10, with clinical evaluations and blood samples collected periodically. The goal is to enhance understanding of malaria's impact on maternal and child health, which could inform vaccine development.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

A study participant must satisfy the following criteria to be or have been enrolled in this study:

1. Pregnant women aged 15-45 years and their newborn infants who are residents of the district of Ouelessebougou for at least one year at the time of enrollment (cohort completed clinical follow up; sample and data analysis ongoing); OR
2. Children who previously participated in the 1st cohort of "pregnant women and their newborn infants", OR
3. Children aged 3 years or less, who are residents of the district of Ouelessebougou for at least one year at the time of enrollment (cohort completed clinical follow up; sample and data analysis ongoing), OR
4. Febrile hospitalized children (aged 0-10 years), including those with positive and negative blood smears for P. falciparum in Ouelessebougou or the pediatric service of Gabriel Toure Hospital in Bamako. Febrile non-hospitalized children (aged 0-10 years) with non-severe malaria will be recruited at outpatient clinics in Ouelessebougou district health hospital and nearby facilities, with no chronic or serious illness.
5. Pregnant women aged 15-25 in Ouelessebougou district health centers or maternity unit of Gabriel Toure Hospital in Bamako and for a case-control study of pregnancy malaria and preeclampsia. Cases include women with signs/symptoms of preeclampsia. Control pregnant women without signs/symptoms of preeclampsia will be recruited sequentially after identification of individual cases, matched for parity, age (+/-2 years) and pregnancy trimester.(cohort completed clinical follow up; sample and data analysis ongoing)
6. The study participant or parent/guardian understands the study and gives informed consent for participation of themselves and/or their child, and agrees to have samples stored.

EXCLUSION CRITERIA:

A participant will be excluded from the study if any one or more of the following criteria are met:

1. Chronic, debilitating illness, other than malaria, determined by history and physical examination of mother or study participant.
2. Conditions that in the judgment of the investigator could increase the risk to the volunteer.
3. History of previous participation in a malaria vaccine trial.

Where it's running

• Gabriel Toure Hospital
  Bamako, Mali Recruiting
• Ouelessebougou Clinical Research Center
  Wolossébougou, Mali Recruiting

Study contacts

• Principal investigator: Patrick E Duffy, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Michal Fried, Ph.D.
• Email: michal.fried@nih.gov
• Phone: (240) 747-7880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.