Uncomplicated Plasmodium falciparum malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
1. Three-day, three-dose regimen of dihydroartemisinin-piperaquine (Artekin™)
co-formulation: target dose of 2 mg/kg/ once per day of dihydroartemisinin and target dose of 18 mg/kg/once per day of piperaquine
2. Three-day, six-dose regimen of artemether-lumefantrine (Coartem®)
co-formulation containing 20 mg of artemether and 120 mg of lumefantrine:
2.1. 5 kg to less than 15 kg: one tablet/twice per day
2.2. 15 kg to less than 25 kg: two tablets/twice per day
2.3. 25 kg to
Sponsors
University of Heidelberg School of Medicine (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged between 6 months and 59 months inclusive 2. Body weight of 5 kg and above 3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/µL to 200,000/µL) 4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C) 5. Signed informed consent by the parents or guardians 6. Parents? or guardians? willingness and ability to comply with the study protocol for the duration of the trial
Exclusion criteria
Exclusion criteria: 1. Participation in any investigational drug study during the previous 30 days 2. Known hypersensitivity to the study drugs 3. Severe malaria 4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand 5. Electrocardiogram (ECG) abnormality that requires urgent management 6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study 7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The cure ratio of dihydroartemisinin-piperaquine is non-inferior to that of artemether-lumefantrine (non-inferiority margin = 5%) 2. The cure ratio of dihydroartemisinin-piperaquine is at least 90% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Polymerase chain reaction (PCR)-uncorrected day 28 cure ratio 2. Safety profiles of the two treatments 3. Time to asexual parasite clearance (PCT) 4. Time to fever clearance (FCT) 5. Gametocyte prevalence and density on days 7, 14, 28, 42, 63 and 84 6. Haematological recovery (Haemoglobin [Hb] changes) from day 0 to day 28, day 42, and day 84 7. Cure ratios at day 42 (PCR corrected and PCR uncorrected) 8. Cure ratios at day 63 (PCR corrected and PCR uncorrected) 9. Cure ratios at day 84 (PCR corrected and PCR uncorrected) 10. Rate of PCR-confirmed reinfections to estimate the chemoprophylactic effect of dihydroartemisinin-piperaquine | — |
Countries
Kenya
Outcome results
None listed