Malaria
Conditions
Interventions
Artemether lumefantrine plus single low dose primaquine
Dihydroartemisinin piperaquine plus single low dose primaquine
Dihdroartemisinin piperaquine plus single low dose primaquine
Sponsors
Bill and Melinda Gates Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Living within 20 km of the catchment of the health facility 2) Volunteer to give the address or phone number and willing to not travel for the duration of the study 3) Volunteer to comply with the study protocol, visit schedule, or get traced in case defaulted 4) Able to give informed consent, assent, and/or parental/guardian permission 5) Age = 2 years 6) Weight = 5.0 kg 7) Axillary temperature = 37.5º C or history of fever during the previous 48 hours 8) Ability to swallow oral medication. 9) Slide-confirmed mono-species infection with P. falciparum (1,000-200,000 parasites/uL, and = 16 gametocytes/uL for transmission study arms) or 10, 000/ul for parasite clearance rate assessment arm.
Exclusion criteria
Exclusion criteria: 1) General danger signs or symptoms of severe malaria 2) Mixed Plasmodium infection 3) Severe anemia, defined as hemoglobin (Hb) 10 years) 4) Has taken a full dose of antimalarials in the last 28 days 5) Presence of febrile conditions caused by diseases other than malaria 6) Serious or chronic medical condition requiring permanent care (e.g. known cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS) 7) Pregnant or breastfeeding 8) Refusal to take pregnancy test for women of child-bearing age (defined as 12–49 years old or menstruating) 9) History of hypersensitivity to study or rescue medication in this study 10) Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy 11) Children weighing less than 5 kilograms 12) Severe malnutrition in children aged between 6-59 months as defined by presence of symmetrical edema involving at least the feet or a mid-upper arm circumference < 115 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the AL and day 7 post-treatment in the DP arm. ;Adequate clinical and parasitological responses | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean mosquito infection rate, 2. mean oocyst intensity in infected mosquitoes, 3. Male and female gametocyte prevalence and density, and sex ratio, 4. Cumulative gametocyte circulation time, 5. Cumulative gametocyte area under the curve, 6. parasite and gametocyte clearance, and density in mutant and wild types | — |
Countries
Ethiopia
Contacts
Public ContactGudissa Assefa
Malaria and Other Vector Borne Disease Prevention and Control Desk Lead
Outcome results
None listed