Malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Dihydroartemisinin + Piperaquine (DHA + PPQ, Artekin ®) tablets containing 20 mg or 40 mg of Dihydroartemisinin and 160 mg or 320 mg of Piperaquine in comparison with Artemether + Lumefantrine (A + L,
Sponsors
Sigma-Tau (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and Females aged between six months and 59 months inclusive 2. Body weight at least 5 kg 3. Microscopically confirmed, monoinfection of Plasmodium falciparum 4. History of fever or presence of fever (axillary temperature at more than or equal to 37.5°C) 5. Written informed consent. 6. 1500 patients (1000 DHA + PPQ; 500 A + L)
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Day 28, Polymerase Chain Reaction (PCR) corrected cure rates of Artekin and Coartem. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the uncorrected Day 28 cure rates of both drugs 2. Comparison of the safety profiles of the two treatments 3. Comparison of times of parasite clearance 4. Comparison of time of fever clearance 5. Comparison of gametocytes (prevalences and densities) 6. Comparison of haemoglobin (Hb) changes from day zero to day 28 7. Comparison of cure rates at D42 (PCR corrected and uncorrected) | — |
Countries
Burkina Faso, Kenya, Mozambique, Uganda, Zambia
Outcome results
None listed