MalariaNCT04105855
Malaria Prevalence Around Maferinyah, Guinea
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Guinea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 3,392 participants
- Where
- 1 siteGuinea
- Study dates
- 13 Jul 2020to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant women greater than or equal to 18 years of age (or emancipated minors) reporting for routine antenatal care at the health center without acute illness
- The study participant understands the study and gives informed consent for participation
- Willingness to share a positive test result for malaria or helminths with the health center in Maf(SqrRoot)(Registered Trademark)rinyah so treatment can be initiated if necessary
- Willingness to allow stored laboratory specimens to be used for future research
- For children, a study participant must satisfy the following criteria to be enrolled in this study:
Show all 10Show fewer
- Children 6-12 months of age at time of visit presenting for routine care at the health center without acute illness
- The parent or guardian understands the study and gives informed consent for participation of their child
- Willingness of parent/guardian to share a positive test result for malaria or helminths with the health center in Maferinyah so treatment can be initiated if necessary
- Willingness of parent/guardian to allow stored laboratory specimens to be used for future research
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Sectional Survey of Plasmodium and Other Parasites in Pregnant Women and Infants Around Maferinyah, Guinea
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Malaria
- Keywords
- Organism, Seasonal, Blood Smear, Burden, Infections, Natural History
- Medical subject headings
- Malaria, Infections
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 |
|---|---|---|
| Older Infants | Infants age 6-12 months presenting for routine healthy visits | |
| Pregnant Women | Women 18 years and older (and emancipated minors) presenting for routine antenatal visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants
seasonal burden of Plasmodium falciparum infection
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start13 Jul 2020
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cross-sectional
- Enrolment
- 3,392 participants (actual)
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
- NCT04105855
- Sponsor's protocol ID
- 999919141
- Other IDs
- 19-I-N141
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwan JL, Seitz AE, Fried M, Lee KL, Metenou S, Morrison R, Kabyemela E, Nutman TB, Prevots DR, Duffy PE. Seroepidemiology of helminths and the association with severe malaria among infants and young children in Tanzania. PLoS Negl Trop Dis. 2018 Mar 26;12(3):e0006345. doi: 10.1371/journal.pntd.0006345. eCollection 2018 Mar.
PubMed 29579050Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31.
PubMed 29396010
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Survey of Plasmodium and Other Parasites in Pregnant Women and Infants Around Maferinyah, Guinea
- ClinicalTrials.gov ID
- NCT04105855
- Acronym / sponsor ID
- 999919141
- Conditions
- Malaria
- Keywords
- Organism, Seasonal, Blood Smear, Burden, Infections, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,392 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Infants | – | –Infants age 6-12 months presenting for routine healthy visits |
| Pregnant Women | – | –Women 18 years and older (and emancipated minors) presenting for routine antenatal visits |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (10 listed)
- For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant women greater than or equal to 18 years of age (or emancipated minors) reporting for routine antenatal care at the health center without acute illness
- The study participant understands the study and gives informed consent for participation
- Willingness to share a positive test result for malaria or helminths with the health center in Maf(SqrRoot)(Registered Trademark)rinyah so treatment can be initiated if necessary
- Willingness to allow stored laboratory specimens to be used for future research
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants
Time frame: 3 years
seasonal burden of Plasmodium falciparum infection
1 secondary outcome
Estimate of the frequency of parasitemia due to non-falciparum malaria
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 29579050Kwan JL, Seitz AE, Fried M, Lee KL, Metenou S, Morrison R, Kabyemela E, Nutman TB, Prevots DR, Duffy PE. Seroepidemiology of helminths and the association with severe malaria among infants and young children in Tanzania. PLoS Negl Trop Dis. 2018 Mar 26;12(3):e0006345. doi: 10.1371/journal.pntd.0006345. eCollection 2018 Mar.
- Background: PubMed 29396010Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick E Duffy, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.