Understanding malaria infection and disease in pregnant women and young children in Mali
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
This study is trying to understand how malaria affects pregnant women and young children in Mali to help improve health and develop better vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 1 Day to 45 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 2 sites (Bamako and 1 other locations) |
| Trial ID | NCT01168271 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 15-45 years and their newborns, as well as children aged 0-10 years residing in the Ouelessebougou district.
Not a fit: Patients with chronic or serious illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for malaria in pregnant women and young children, ultimately reducing morbidity and mortality.
How similar studies have performed: Other studies have shown success in understanding malaria's effects on pregnancy and childhood, but this specific approach is novel in its comprehensive longitudinal design.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: A study participant must satisfy the following criteria to be 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; 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, 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. 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 this trial is running
Bamako and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.