Antimalarial safety in early pregnancy (first trimester)
Official title: A Multicentre Open-label, Non-inferiority Adaptive Platform Randomised Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Antimalarials for the Treatment of Uncomplicated Malaria in the First Trimester of Pregnancy: Master Protocol
Run by Liverpool School of Tropical Medicine · NCT06962319 · Data updated 2026-11-12
This trial will test whether three antimalarial medicines—dihydroartemisinin‑piperaquine, pyronaridine‑artesunate, and artemether‑lumefantrine—are safe and work well for pregnant women with uncomplicated malaria in their first trimester.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 1510 (estimated) |
| Sponsor | Liverpool School of Tropical Medicine Academic / other |
| Locations | 3 sites (Nanoro and 2 other locations) |
| Status | Recruiting |
| Started | September 30, 2025 |
| Main results expected | August 2028 |
| Study ends | August 2029 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT06962319 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people aged 16 or older with microscopy‑confirmed P. falciparum infection between roughly 2 and 13+6/7 weeks gestation, hemoglobin ≥7 g/dL, who live in the local catchment area and are willing to follow study procedures and deliver at the study facility are ideal candidates.
✕Probably not a fit
People with severe malaria, major concurrent illnesses, known HIV infection, a history of major pregnancy complications, known allergy to study drugs, or who cannot remain in the catchment area or deliver at the facility would be excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SAFIRE is a Phase 3, multi‑center interventional trial testing commonly used artemisinin‑based combination therapies in women with microscopy‑confirmed P. falciparum infection between about 2 and 13+6/7 weeks gestation. Eligible participants are enrolled at sites in Burkina Faso, Mali, and Kenya and are assigned to receive one of the antimalarial regimens under close clinical and obstetric monitoring. The trial collects safety data on maternal and fetal outcomes, treatment tolerability, and parasitological clearance, with follow‑up through delivery and newborn assessment. Results aim to provide more robust first‑trimester human data to inform treatment guidance in malaria‑endemic settings.
Why it matters
Potential benefit: If successful, the trial could expand safe, effective antimalarial options in the first trimester and reduce reliance on older, less effective drugs, improving outcomes for mothers and babies.
How similar studies have gone: Observational data and inadvertent first‑trimester exposures support the safety of artemether‑lumefantrine in pregnancy, but randomized and robust first‑trimester data for other ACTs remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥2 weeks and \<14 weeks (13-6/7 weeks inclusive) gestation from the last menstrual period (LMP) as assessed by echography * Microscopy confirmed P. falciparum mono or mixed infections, regardless of symptoms. * Emancipated minor and aged ≥16 years * Haemoglobin ≥ 7 g/dL * Residence within the health facility catchment area * Willingness to adhere to study requirements and to deliver the baby at the local health facility * Willingness to adhere to study requirements and to deliver the baby at the local health facility Exclusion Criteria: * Known allergy to any of the study drugs * History of known pregnancy complications or poor obstetric history, such as repeated miscarriages, stillbirths, or eclampsia * History or presence of major illnesses likely to influence pregnancy outcome * Known HIV positive * Any significant illness at the time of screening requiring hospitalisation, including severe malaria * Intent to move out of the study catchment area before delivery or planned delivery out of the catchment area * Recent (2 weeks) treatment with antimalarials or antimicrobials with antimalarial activity (chloroquine, AL, DP, PA, SPAQ, ASAQ, MQAS, azithromycin, clindamycin, tetracycline, quinolones, cotrimoxazole and SP) * Twin/multiple pregnancy detected * Non-viable pregnancy confirmed by ultrasound or doppler * Known history or evidence of clinically significant cardiovascular disorders or family history of sudden death or congenital long QT syndrome or current co administration of other drugs that might contribute to a prolonged QTc interval or cause "Torsades de Point" * Chronic medical condition requiring frequent medications (e.g., TB, suspected hepatic lesions, liver disease, sickle cell disease, diabetes, epilepsy, asthma and hypertension) * Prior randomisation in this study during the current pregnancy
Where it's running
-
Malaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako (USTTB),
Bamako, Mali Recruiting -
Clinical Research Unit of Nanoro (CRUN), Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO)
Nanoro, Burkina Faso Not yet recruiting -
KEMRI Centre for Global Health Research (CGHR)
Kisumu, Kenya Not yet recruiting
Study contacts
- Principal investigator: Fieko ter Kuile, MD — Liverpool School of Tropical Medicine
- Study coordinator: Amy Smith
- Email: Amy.Smith@lstmed.ac.uk
- Phone: +44 151 702 9575
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.