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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 currently recruiting participants.
Verified December 15, 2016 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168271
First Posted: July 23, 2010
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
  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. In addition, 2000 febrile children up to age 10 years will be enrolled at the Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) 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 Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. 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: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Primary Outcome Measures:
  • To assess the relationship between malaria exposure during pregnancy and maternal and fetal outcomes [ Time Frame: Pregnant women will be followed 4 wks sp/delivery. Newborns will be followed for 5 yrs. Ages 0-3 yrs will be followed until they reach age 5 yrs. Hospitalized children will be followed 4 wks after admission. ]
  • Identify factors (in the mother, placenta, fetus, offspring or parasite) associated with susceptibility or resistance to malaria infection and disease in children and pregnant women [ Time Frame: Pregnant women will be followed 4 wks sp/delivery. Newborns will be followed for 5 yrs. Ages 0-3 yrs will be followed until they reach age 5 yrs. Hospitalized children will be followed 4 wks after admission. ]

Estimated Enrollment: 15000
Study Start Date: June 30, 2010
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 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. In addition, 2000 febrile children up to age 10 years will be enrolled at the Ouelessebougou district health centers or the Gabriel Tour(SqrRoot)(Copyright) 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 Tour(SqrRoot)(Copyright) Hospital in Bamako for a case-control study on pregnancy malaria and preeclampsia. 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

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 aged 3 years or less, who are residents of the district of Ouelessebougou for at least one year at the time of enrollment; OR
  3. 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 pregnant women aged 15-25 in Ouelessebougou district health centers or maternity unit of Gabriel Toure Hospital iin Bamako 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.

  4. 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 fo 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168271


Contacts
Contact: Michal Fried, Ph.D. (301) 402-0763 michal.fried@nih.gov
Contact: Patrick E Duffy, M.D. (301) 761-5089 duffype@niaid.nih.gov

Locations
Mali
Gabriel Toure Pediatric Hospital Recruiting
Bamako, Mali
Ouelessebougou Clinical Research Center/MRTC/FMPOS Recruiting
Ouelessebougou, Mali
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Patrick E Duffy, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01168271     History of Changes
Other Study ID Numbers: 999910156
10-I-N156
First Submitted: July 22, 2010
First Posted: July 23, 2010
Last Update Posted: October 19, 2017
Last Verified: December 15, 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Observational
Newborns
Hospitalized
Febrile
Resistance

Additional relevant MeSH terms:
Malaria
Disease Susceptibility
Protozoan Infections
Parasitic Diseases
Disease Attributes
Pathologic Processes