Malaria
Conditions
Interventions
Sponsors
USAID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent, assent and/or parental/guardian permission 2. Age = 6 months 3. Weight = 5.0 kg 4. Hemoglobin = 7 g/dl 5. Axillary temperature = 37.5º C or history of fever during the previous 24 hours 6. Ability to swallow oral medication 7. Slide-confirmed P. falciparum mono-infection with parasite density = 1000 parasites per µL.
Exclusion criteria
Exclusion criteria: 1. General danger signs or symptoms of severe malaria 2. Mixed Plasmodium infection 3. Anemia defined as hemoglobin < 7 g/dl 4. Presence of febrile conditions caused by diseases other than malaria 5. Serious or chronic medical condition 6. Pregnant or breastfeeding 7. Refusal to take pregnancy test for women of childbearing age ( 12–49 years) 8. History of hypersensitivity to study or rescue medication in this study 9. Taking regular medication which may interfere with antimalarial pharmacokinetics or efficacy 10. Children weighing less than 5 kilograms 11. Severe malnutrition in children aged between 6-59 months as defined by the presence of symmetrical edema involving at least the feet or a mid-upper arm circumference < 115 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical and parasitological response | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Document genetic polymorphisms implicated in antimalarial drug resistance 2. Distinguish reinfections and recrudescent infections 3. Compare the transmissibility of P. falciparum parasites with delayed and rapid parasite clearance and markers of drug resistance 4. Identify genetic changes related to signs of delayed parasite clearance or resistance 5. Determine fever, parasite and antigen clearance rates as measured by microscopy adjusted by 18S-based quantitative PCR 6. Assess hematological responses 7. Assess pfhrp2/3 gene deletion among P. falciparum-infected patients | — |
Countries
Ethiopia
Contacts
Public ContactGudissa Assefa
Malaria and Other Vector Borne Disease Prevention and Control Desk Lead
Outcome results
None listed