Could treating the whole family stop malaria in pregnancy?
NCT ID NCT07021430
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times
Summary
This pilot study tests whether giving a malaria drug (dihydroartemisinin piperaquine) to household members of pregnant women can help prevent malaria in the mothers. About 300 participants in Uganda will receive either a single dose or monthly doses. The goal is to see if this approach is feasible, acceptable, and shows early signs of working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dihydroartemisinin Piperaquine (a malaria drug)
- What this could lead to
- If it works, this could point toward a new way to protect pregnant women from malaria by treating their family members.
- What could go wrong
- This is a very early pilot study with only 300 people, so it may not show clear benefits or be too small to prove effectiveness. The approach may also be hard to scale or accept in communities.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months * Able and willing to comply with all study procedures and be available for the duration of the study * Able and willing to consent to study procedures as documented on informed consent form. For children (age \<18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent. Each pregnant women will also need to meet additional eligibility criteria: 18 years old or older Presenting to Bugoye Level III Health Center for antenatal care and plan to deliver at Bugoye Level III Health Center (i.e., not planned cesarean section) Gestational age ≤22 weeks Human Immunodeficiency Virus negative Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation: * Temporary or part-time residence in Kasese District (i.e., where a person lives for \< 6 months per year) * Known plans to move within the next 6 months * Unable or unwilling to provide consent * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study In addition, individuals with any of the following will still be eligible to participate (e.g,, complete surveys, provide blood samples) but will not be eligible to receive Dihydroartemisinin Piperaquine if randomized to one of the intervention arms: * Known arrythmia, QT prolongation, or seizure disorder will not be eligible to receive Dihydroartemisinin Piperaquine * Use of potentially contraindicated medications outlined in Section 5.6 * Weight \<5 kg * Known allergic reaction to Dihydroartemisinin Piperaquine or other Artemisinin Combination Therapies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bugoye Level III Health Center
RECRUITINGKasese, Uganda
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