Status:
RECRUITING
Safety of Antimalarials in the FIRst trimEster
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborating Sponsors:
Malaria Research and Training Center, Mali International Center of Excellence in Research, University of Sciences, Techniques, and Technologies of Bamako, Mali
KEMRI Centre for Global Health Research (CGHR), Kisumu, Kenya
Conditions:
Malaria, Pregnancy
Malaria, Antepartum
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
The SAFIRE study aims to find effective treatments with acceptable safety for malaria in early pregnancy, a particularly sensitive time for the adverse consequences of malaria in pregnancy for both mo...
Detailed Description
Background: Malaria in pregnancy remains a substantial public health concern in endemic regions, with first-trimester infections being particularly harmful. The World Health Organization (WHO) now rec...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
1510 Patients enrolled
Trial Details
Trial ID
NCT06962319
Start Date
September 30 2025
End Date
August 1 2029
Last Update
November 19 2025
Active Locations (3)
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1
Clinical Research Unit of Nanoro (CRUN), Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO)
Nanoro, Burkina Faso
2
KEMRI Centre for Global Health Research (CGHR)
Kisumu, Kenya, 40100
3
Malaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako (USTTB),
Bamako, Mali, 1805