MalariaNCT03719599
Plasmodium and Other Parasites in Pregnant Women and Children Around Margibi and Montserrado Counties, Liberia
An observational study of Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Liberia.
Trial summary
Background: The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria
- How many people
- 1,264 participants
- Where
- 2 sitesLiberia
- Study dates
- 1 Oct 2019to 4 Feb 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women 18 years of age and older and children 6-12 months of age presenting for routine visits at C.H. Rennie Hospital in Margibi, and Dupont Road Health Center in Monrovia.@@@
Who may be able to join
- For pregnant women, a study participant must satisfy the following criteria to be enrolled in this study:
- Pregnant woman >=18 years of age reporting for routine care at the center without acute illness or abnormal vital signs (e.g.fever, SBP > 160, OR DBP > 110) per standard clinic procedures
- 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 C.H. Rennie Hospital or the Duport Road Health Center so treatment can be initiated if necessary
- For children, a study participant must satisfy the following criteria to be enrolled in this study:
- Children 6-12 months of age at time of visit presenting for routine care at the center without acute illness or abnormal vital signs (e.g. fever) per standard clinic procedures
- 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 C.H. Rennie Hospital or the Duport Road Health Center so treatment can be initiated if necessary
Who cannot join
- For women, prior enrollment in the study during the same pregnancy
- For children, prior enrollment in the study
- 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 (examples to consider may include severe acute illness at the time of enrollment, psychiatric conditio (s) that may preclude compliance with the protocol, and suspected or known drug abuse). All such exclusions and the reason for exclusion will be documented.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Cross-Sectional Survey of Plasmodium and Other Parasites in Pregnant Women and Children Around Margibi and Montserrado Counties, Liberia
Background:
The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Worms also infect many people in Liberia. They can be caused by mosquito bites or by touching soil or still water. Worm infections can be mild or serious. Doctors in Liberia and their NIH partners want to learn more about these diseases in women and children.
Read more
Objective:
To measure how much malaria and worm infections there are in pregnant women and children in two counties of Liberia.
Eligibility:
Pregnant women ages 18 and older and children ages 6 12 months seeking routine care at C.H. Rennie Hospital or the Duport Road Health Center
Design:
Participants will be screened with questions about their health or their child s health.
Participants will be asked further questions about their health and about their home life.
Participants will give a small amount of blood by finger prick. This will be tested to see if they have malaria or some types of worms, and for research studies.
Participants who are sick from malaria will be treated at a study clinic. Treatment will follow standards of the Liberia and/or the World Health Organization.
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 of 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 Margibi and Montserrado is sufficient to support future studies of malaria pathogenesis and immunity. In addition to assessing malaria burden this study will build up diagnostic laboratory capacity for malaria diagnostics. We plan to enroll 2920 pregnant women and 2920 children (6-12 months of age) into a cross sectional study that will be conducted in Margibi and Montserrado counties, Liberia. Women presenting for routine antenatal visits and presenting for well-baby clinic visits (e.g. vaccinations, vitamins) at C.H. Rennie Hospital in Margibi or Duport Road Health Center in Montserrado will be enrolled. Samples collected from the women and children will be examined for evidence of infection by Plasmodium and other parasitic diseases in order to assess prevalence in this key reservoir population. 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 these sites. For our secondary outcomes, we will determine the prevalence of other parasitic diseases, such as filaria, S. stercoralis, and schistosomes by serologic assays of blood samples.
- Conditions
- Malaria
- Keywords
- Malaria, Infection, Seasonal, Parasitemia, Organism, Natural History
- Medical subject headings
- Malaria, Infections, Parasitemia
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 | Children 6 -12 months of age presenting for routine clinic visits | |
| Pregnant Women | Pregnant Women 18 years and older presenting for routine clinic visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears
The frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears
Measured: Seasonal and year of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Oct 2019
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
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
- 1,264 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
- NCT03719599
- Sponsor's protocol ID
- 999919007
- Other IDs
- 19-I-N007
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2018
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogerson 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 29396010Kwan 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 29579050
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. 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 Children Around Margibi and Montserrado Counties, Liberia
- ClinicalTrials.gov ID
- NCT03719599
- Acronym / sponsor ID
- 999919007
- Conditions
- Malaria
- Keywords
- Malaria, Infection, Seasonal, Parasitemia, Organism, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,264 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 25 Oct 2018 (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:
The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Worms also infect many people in Liberia. They can be caused by mosquito bites or by touching soil or still water. Worm infections can be mild or serious. Doctors in Liberia and their NIH partners want to learn more about these diseases in women and children.
Objective:
To measure how much malaria and worm infections there are in pregnant women and children in two counties of Liberia.
Eligibility:
Pregnant women ages 18 and older and children ages 6 12 months seeking routine care at C.H. Rennie Hospital or the Duport Road Health Center
Design:
Participants will be screened with questions about their health or their child s health.
Participants will be asked further questions about their health and about their home life.
Participants will give a small amount of blood by finger prick. This will be tested to see if they have malaria or some types of worms, and for research studies.
Participants who are sick from malaria will be treated at a study clinic. Treatment will follow standards of the Liberia and/or the World Health Organization.
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 of 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 Margibi and Montserrado is sufficient to support future studies of malaria pathogenesis and immunity. In addition to assessing malaria burden this study will build up diagnostic laboratory capacity for malaria diagnostics. We plan to enroll 2920 pregnant women and 2920 children (6-12 months of age) into a cross sectional study that will be conducted in Margibi and Montserrado counties, Liberia. Women presenting for routine antenatal visits and presenting for well-baby clinic visits (e.g. vaccinations, vitamins) at C.H. Rennie Hospital in Margibi or Duport Road Health Center in Montserrado will be enrolled. Samples collected from the women and children will be examined for evidence of infection by Plasmodium and other parasitic diseases in order to assess prevalence in this key reservoir population. 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 these sites. For our secondary outcomes, we will determine the prevalence of other parasitic diseases, such as filaria, S. stercoralis, and schistosomes by serologic assays of blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children 6 -12 months of age presenting for routine clinic visits |
| Pregnant Women | – | –Pregnant Women 18 years and older presenting for routine clinic visits |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women 18 years of age and older and children 6-12 months of age presenting for routine visits at C.H. Rennie Hospital in Margibi, and Dupont Road Health Center in Monrovia.@@@
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- For women, prior enrollment in the study during the same pregnancy
- For children, prior enrollment in the study
- 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 (examples to consider may include severe acute illness at the time of enrollment, psychiatric conditio (s) that may preclude compliance with the protocol, and suspected or known drug abuse). 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
Measurement of the frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears
Time frame: Seasonal and year of sample collection
The frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears
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 18 Mar 2026.
- 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.
- 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.
- Individual participant dataSharing planned: No
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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)
2 sites 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 2 sites in Liberia.
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 8 inclusion and 3 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Liberia. 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?
Measurement of the frequency of P. falciparum parasitemia as defined by rapid diagnostic tests and/or blood smears (time frame: Seasonal and year of sample collection). 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 NCT03719599, 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 18 Mar 2026.