A phase III, randomised, non-inferiority trial, to assess the efficacy and safety of Dihydroartemisinin and Piperaquine (DHA + PPQ, Artekin®) in comparison with Artemether and Lumefantrine (A + L, Coartem®) in children with uncomplicated Plasmodium falciparum malaria
Completed
- Conditions
- MalariaInfections and InfestationsPlasmodium falciparum malaria
- Registration Number
- ISRCTN16263443
- Lead Sponsor
- Sigma-Tau (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1500
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Day 28, Polymerase Chain Reaction (PCR) corrected cure rates of Artekin and Coartem.
- Secondary Outcome Measures
Name Time Method 1. Comparison of the uncorrected Day 28 cure rates of both drugs <br>2. Comparison of the safety profiles of the two treatments<br>3. Comparison of times of parasite clearance<br>4. Comparison of time of fever clearance<br>5. Comparison of gametocytes (prevalences and densities)<br>6. Comparison of haemoglobin (Hb) changes from day zero to day 28<br>7. Comparison of cure rates at D42 (PCR corrected and uncorrected)