Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed, and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Childhood malaria is a major cause of mortality, and we have found that risk of childhood malaria is related to in utero exposure to pregnancy malaria, as well as other host factors like iron status and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding phenotype, and as our primary hypothesis in this study we speculate that severe childhood malaria parasites may also have distinct features. A longitudinal cohort study will be conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000 pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples obtained. Clinical, parasitologic and host response (including immunologic) endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine factors associated with infection and disease in pregnant woman and young children.
| Condition |
|---|
|
Malaria |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali |
- Changes in blood pressure related to malaria in pregnancy and clinical malaria in infants and children
| Estimated Enrollment: | 15000 |
| Study Start Date: | June 2010 |
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences. A greater understanding of the immunologic and parasitologic factors associated with infection and disease is badly needed, and will accelerate the development of highly protective vaccines for both mothers and children. Pregnancy malaria is associated with low birth weight, maternal anemia, and gestational hypertension, and both inflammation and the fetal response to infection may contribute to these poor outcomes. Childhood malaria is a major cause of mortality, and we have found that risk of childhood malaria is related to in utero exposure to pregnancy malaria, as well as other host factors like iron status and constitutive cytokine levels. Pregnancy malaria is caused by a distinct parasite binding phenotype, and as our primary hypothesis in this study we speculate that severe childhood malaria parasites may also have distinct features. A longitudinal cohort study will be conducted in Ouelessebougou, Mali an area of intense seasonal transmission. Up to 2000 pregnant women and their infants and 2000 children ages 0 - 3 will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples obtained. Clinical, parasitologic and host response (including immunologic) endpoints will be analyzed using appropriate statistical methods, including possible confounders, to determine factors associated with infection and disease in pregnant woman and young children.
Eligibility| Ages Eligible for Study: | up to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
A study participant must satisfy the following criteria to be enrolled in this study:
- 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
- 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
- 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, AND
- 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:
- Chronic, debilitating illness, other than malaria, determined by history and physical examination fo mother or study participant.
- Conditions that in the judgment of the investigator could increase the risk to the volunteer.
- History of previous participation in a malaria vaccine trial.
Contacts and Locations| Contact: Michal Fried, Ph.D. | (301) 402-0763 | michal.fried@nih.gov |
| Contact: Patrick E Duffy, M.D. | (301) 443-4605 | duffype@niaid.nih.gov |
| Mali | |
| Gabriel Toure Pediatric Hospital | Recruiting |
| Bamako, Mali | |
| Ouelessebougou Clinical Research Center/MRTC/FMPOS | Recruiting |
| Ouelessebougou, Mali | |
| Principal Investigator: | Patrick E Duffy, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT01168271 History of Changes |
| Other Study ID Numbers: | 999910156, 10-I-N156 |
| Study First Received: | July 22, 2010 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Observational Newborns Hospitalized Febrile Resistance |
Additional relevant MeSH terms:
|
Disease Susceptibility Genetic Predisposition to Disease Malaria Disease Attributes |
Pathologic Processes Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013