Malaria Paediatrics
Conditions
Interventions
Artemether Lumefantrine
Dihydroartemisinin piperaquine DHA PQ
Artesunate mefloquine ASMQ
Pyronaridine artesunate PA
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 6–59 months and weight = 5 kg Microscopy- or RDT-confirmed P. falciparum monoinfection, 2 000–200 000 parasites µL?¹ Fever = 37.5 °C (axillary) or history of fever within 24 h and no WHO danger signs Laboratory safety windows – Hb = 7 g dL?¹, ALT/AST = 3 × ULN, CrCl = 50 mL min?¹ 1.73 m?², platelets = 100 × 10? L?¹ Screening QTcF < 450 ms No antimalarial intake in the preceding 14 days No concomitant QT-prolonging or interacting medications Written informed consent from parent/guardian (plus age-appropriate assent) and commitment to follow-up through Day 63
Exclusion criteria
Exclusion criteria: Any WHO criterion for severe malaria (e.g., Hb < 5 g dL?¹, prostration, repeated convulsions, organ dysfunction) Mixed or non-falciparum infection Severe malnutrition (WHZ < –3 or MUAC < 11.5 cm) Known HIV infection on ART with strong CYP3A4 modulators Cardiac, hepatic or renal disease beyond threshold labs; QTcF = 450 ms History of hypersensitivity to artemisinins or partner drugs Participation in another interventional study within 30 days Social or logistical barriers to follow-up (e.g., planned relocation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 42 PCR-corrected adequate clinical and parasitological response (ACPR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Day 28 and Day 63 PCR-corrected ACPR parasite. 2. Fever clearance kinetics. 3. Parasitaemia half-life. 4. Gametocyte carriage on Days 7 and 14. 5. Treatment-emergent adverse events and laboratory shifts. 6 Pharmacokinetic target attainment. 7. Implementation fidelity and acceptability. 8. Health economic evaluation | — |
Countries
Uganda
Contacts
Public ContactDenis Amorut
Trial Manager
Outcome results
None listed