MalariaNCT01168271
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Mali.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 15,000 participants
- Where
- 2 sitesMali
- Study dates
- 30 Aug 2010to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women presenting for antenatal consultations and delivery and their newborns; children aged 0-3 years in Ouelessebougou and Febrile children ages 0-10 years hospitalized and non-hospitalized in Ouelessebougou or the Pediatric service of Gabriel Toure Hospital in Bamako; Re-enrollees who were originally enrolled at birth and completed the Pregnant Women and Newborn Cohort
Who may be able to join
- A study participant must satisfy the following criteria to be or have been 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 (cohort completed clinical follow up; sample and data analysis ongoing); OR
- Children who previously participated in the 1st cohort of "pregnant women and their newborn infants", 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 (cohort completed clinical follow up; sample and data analysis ongoing), 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. 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.
- 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)
- 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.
Who cannot join
- 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 of 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mali2 sites, 2 recruiting
- Recruiting
Gabriel Toure Hospital
Bamako
Almahamoudou Mahamar, Pharm.D., 223-7623-250, almahamar@icermali.org
- Recruiting
Ouelessebougou Clinical Research Center
Wolossébougou
Almahamoudou Mahamar, 223-7623 250, almahamar@icermali.org
About this study
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 its risk 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 aged 0-3 years will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples being obtained. In addition, up to 3000 febrile hospitalized and non-hospitalized children up to 10 years ofd age will be enrolled at the Ouelessebougou district health centers or the Gabriel Toure Pediatric Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel Toure Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. Up to 1000 children originally enrolled at birth and completed the "pregnant women and their newborns study" will be re-enrolled and followed for up to 10 years as they age from later childhood through adolescence to early adulthood. 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 women and young children....
Read the detailed description
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 its risk 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 aged 0-3 years will be enrolled and followed to age 5 years, with clinical evaluation and periodic venous and peripheral blood samples being obtained. In addition, up to 3000 febrile hospitalized and non-hospitalized children up to 10 years ofd age will be enrolled at the Ouelessebougou district health centers or the Gabriel Toure Pediatric Hospital in Bamako, Mali, with acute and convalescent samples being obtained and 500 pregnant women enrolled at the health centers and hospital in Ouelessebougou district or the Gabriel Toure Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. Up to 1000 children originally enrolled at birth and completed the "pregnant women and their newborns study" will be re-enrolled and followed for up to 10 years as they age from later childhood through adolescence to early adulthood. 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 women and young children.
- Conditions
- Malaria
- Keywords
- Observational, Newborns, Hospitalized, Febrile, Resistance, Natural History
- Medical subject headings
- Malaria, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children Ages 0-3 years | Children aged 0-3 years in Ouelessebougou | |
| Febrile Hospitalized Children | Febrile hospitalized children aged 0-10 years in Ouelessebougou or the Pediatric service of Gabriel Toure Hospital in Bamako | |
| Later Childhood and Adolescence | Re-enrollees who were originally enrolled at birth and completed the Pregnant Women and Newborn Cohort | |
| Non-Hospitalized Children | Febrile non-hospitalized children aged 0-10 years in Ouelessebougou or the Pediatric service of Gabriel Toure Hospital in Bamako | |
| Pregnant Women + Newborns | Pregnant women presenting for antenatal consultations and delivery and their newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal, placental, parasite and host associated with resistence to malaria infection and diseases in children
To assess the relationship between malaria exposure during pregnancy and maternal and fetal outcomes; and to determine factors (maternal, placental, parasite, and host) associated with susceptibility or resistance to malaria infection and diseases in children
Measured: up to 5 years for infants and children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study start30 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Patrick E Duffy, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168271
- Sponsor's protocol ID
- 999910156
- Other IDs
- 10-I-N156
- Status last verified
- 17 Jun 2026
- First submitted
- 22 Jul 2010
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fried M, Nosten F, Brockman A, Brabin BJ, Duffy PE. Maternal antibodies block malaria. Nature. 1998 Oct 29;395(6705):851-2. doi: 10.1038/27570. No abstract available.
PubMed 9804416Ho M, Singh B, Looareesuwan S, Davis TM, Bunnag D, White NJ. Clinical correlates of in vitro Plasmodium falciparum cytoadherence. Infect Immun. 1991 Mar;59(3):873-8. doi: 10.1128/iai.59.3.873-878.1991.
PubMed 1997437Muehlenbachs A, Mutabingwa TK, Edmonds S, Fried M, Duffy PE. Hypertension and maternal-fetal conflict during placental malaria. PLoS Med. 2006 Nov;3(11):e446. doi: 10.1371/journal.pmed.0030446.
PubMed 17105340Doritchamou JYA, Renn JP, Jenkins B, Mahamar A, Dicko A, Fried M, Duffy PE. A single full-length VAR2CSA ectodomain variant purifies broadly neutralizing antibodies against placental malaria isolates. Elife. 2022 Feb 1;11:e76264. doi: 10.7554/eLife.76264.
PubMed 35103596Mahamar A, Gonzales Hurtado PA, Morrison R, Boone R, Attaher O, Diarra BS, Gaoussou S, Issiaka D, Dicko A, Duffy PE, Fried M. Plasma biomarkers of hemoglobin loss in Plasmodium falciparum-infected children identified by quantitative proteomics. Blood. 2022 Apr 14;139(15):2361-2376. doi: 10.1182/blood.2021014045.
PubMed 34871370Mahamar A, Andemel N, Swihart B, Sidibe Y, Gaoussou S, Barry A, Traore M, Attaher O, Dembele AB, Diarra BS, Keita S, Dicko A, Duffy PE, Fried M. Malaria Infection Is Common and Associated With Perinatal Mortality and Preterm Delivery Despite Widespread Use of Chemoprevention in Mali: An Observational Study 2010 to 2014. Clin Infect Dis. 2021 Oct 20;73(8):1355-1361. doi: 10.1093/cid/ciab301.
PubMed 33846719Fried M, Kurtis JD, Swihart B, Pond-Tor S, Barry A, Sidibe Y, Gaoussou S, Traore M, Keita S, Mahamar A, Attaher O, Dembele AB, Cisse KB, Diarra BS, Kanoute MB, Dicko A, Duffy PE. Systemic Inflammatory Response to Malaria During Pregnancy Is Associated With Pregnancy Loss and Preterm Delivery. Clin Infect Dis. 2017 Oct 30;65(10):1729-1735. doi: 10.1093/cid/cix623.
PubMed 29020221