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Defining safety parameters for first-trimester malaria treatment trials: stakeholder views from Real-Time Delphi
Sandra Bivegete1, Hellen Barsosio1,2, Myriam El Gaaloul3
1Department of Clinical Sciences, Liverpool School of Tropical Medicine (LSTM), Pembroke Place, Liverpool, L3 5QA, UK.
Malaria Journal
|July 18, 2026
Summary
Stakeholders identified critical safety outcomes and non-inferiority margins for malaria drug trials in early pregnancy. This research supports developing safer treatments for pregnant women, addressing drug resistance concerns.
Area of Science:
- Pharmacovigilance
- Clinical Trial Design
- Global Health
Background:
- Artemether-lumefantrine is recommended for malaria in early pregnancy, but resistance necessitates alternative treatments.
- Research on alternative artemisinin-based combination therapies (ACTs) for first-trimester pregnancy is crucial.
- Stakeholder consensus on safety endpoints and non-inferiority margins is needed for robust clinical trials.
Purpose of the Study:
- To establish stakeholder views on safety endpoints for evaluating ACTs in first-trimester pregnancy.
- To determine acceptable non-inferiority margins for randomized controlled trials (RCTs) of ACTs in early pregnancy.
- To inform the design of future malaria treatment trials in pregnant populations.
Main Methods:
- A Real-Time (RT) Delphi survey was conducted with international stakeholders (researchers, regulators, ethicists, practitioners).
- Participants rated the importance of composite and individual maternal/infant safety outcomes using a 5-point Likert scale.
- Quantitative data were summarized descriptively, and qualitative feedback was analyzed thematically.
Main Results:
- A composite endpoint (miscarriage, stillbirth, major congenital anomalies) was supported by 77% of respondents.
- Critical maternal outcomes included death, severe anemia, renal failure, and ICU admission.
- Essential infant outcomes were major congenital anomalies, stillbirth, and neonatal death.
- A non-inferiority margin of HR=1.2 was deemed pragmatic; concerns noted regarding non-specific outcomes like preterm birth.
Conclusions:
- This study provides a framework for defining key safety outcomes and non-inferiority margins in first-trimester malaria treatment trials.
- Incorporating stakeholder perspectives enhances trial design and supports evidence-informed policy.
- Facilitates the deployment of a wider range of antimalarial treatments proven safe for early pregnancy.
