An observational study in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in Guinea. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Many women in Sub-Saharan Africa get malaria while they are pregnant. Plasmodium falciparum is a parasite that can cause malaria. Placental malaria (PM) caused by P. falciparum can cause anemia or death in first-time mothers. In infants, it can cause low birth weight, premature birth, or other problems. Some women don t show any signs of having PM. This makes it harder to know if they might have it. Researchers want to learn how much the seasons affect the number of women and infants who get PM as well as the severity of the disease. To do this, they are going to test women and babies who visit a health center in Guinea.
Objective:
To learn the seasonal burden of P. falciparum infection in pregnant women and otherwise healthy infants.
Eligibility:
Pregnant women ages 18 years and older (or emancipated minors) and infants ages 6-12 months.
Design:
Participants will include women and infants who visit the health center in Maf(SqrRoot)(Registered Trademark)rinyah, Guinea, for routine care. They can take part only once per pregnancy.
For screening, mothers will talk about their medical history. They will talk about their past pregnancies and their current pregnancy. They will answer questions about where they live and what they do to keep from getting malaria. Babies will be screened with their medical history and demographic information.
Participants will also give a blood sample. Adults will have a finger stick. Children will have a heel stick. Or they will have blood taken from a vein.
Participation will last for 1 visit to the health center.
Malaria caused by Plasmodium falciparum continues to be a global problem with devastating consequences, in particular for at-risk populations such as pregnant women and young infants. Pregnancy malaria is associated with low birth weight (LBW), maternal anemia, and gestational hypertension; both inflammation and the fetal response to infection may contribute to these poor outcomes. Placental malaria (PM) is caused by P. falciparum-infected erythrocytes that bind to the placental receptor chondroitin sulfate A (CSA) and sequester in the placenta, where they cause disease and may lead to death for the mother and her offspring. Women become resistant to PM as they acquire antibodies that target surface proteins of placental parasites. In areas of stable transmission, acute severe malaria syndromes are limited to children under 5 years of age. The pathogenesis of severe malaria remains poorly understood, although some evidence suggests that parasites causing severe malaria may express distinct antigens on the surface of infected erythrocytes. Thus, vaccines to prevent malarial disease may need to target distinct antigens in order to protect pregnant women or young children.
The primary hypothesis in this study is that the burden of P. falciparum infection around Maferinyah, Guinea is sufficient to support future studies of malaria pathogenesis and immunity. We plan to enroll 1050 pregnant women and 1050 infants into a cross sectional study that will be conducted in Maferinyah and neighboring areas, Guinea. Women presenting for routine antenatal visits and older infants presenting for routine healthy visits (e.g, vaccinations, vitamins) at the health center in Maf(SqrRoot)(Registered Trademark)rinyah will be offered enrollment. Samples collected from the women and infants will be examined for evidence of infection by Pla smodium and other parasitic diseases in order to assess prevalence in these important reservoir populations. For our primary outcome, we will determine the prevalence of P. falciparum infection in these two key demographic groups, including their annual and seasonal variations, as these data will form the basis to design future natural history or interventional studies at this site. For our secondary outcomes, we will determine the prevalence of other parasitic infections based on multiplexed serologic assessments of blood samples.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 3,392 is above the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant women 18 years of age and older (including emancipated minors) and 6-12 month old infants presenting for routine visits at Maf(SqrRoot)(Registered Trademark)rinyah Health Centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
For children, a study participant must satisfy the following criteria to be enrolled in this study:
EXCLUSION CRITERIA:
-Conditions that in the judgment of the Principal Investigator or Clinical Investigators could adversely impact the safety of the study participant, including conditions that may impair the ability of the participant or participant s parent/guardian to understand the study. All such exclusions and the reason for exclusion will be documented.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants age 6-12 months presenting for routine healthy visits
Women 18 years and older (and emancipated minors) presenting for routine antenatal visits
Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants
seasonal burden of Plasmodium falciparum infection
Time frame: 3 years
Estimate of the frequency of parasitemia due to non-falciparum malaria
The frequency of parasitemia due to non-falciparum malaria and seroprevalence of parasitic infections due to organisms other than Plasmodium (e.g. filarial spp., Schistosoma spp., soil-transmitted helminths) in these cohorts
Time frame: 3 years
Ran from Jul 2020 to primary completion in Oct 2023, 39 months.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →