Malaria Infections and Infestations Malaria
Conditions
Interventions
Subjects who meet the selection criteria will be randomized to treatment with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) and will be followed for 42 days. Repeat evaluations
Sponsors
Uganda Ministry of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 6 – 59 months 2. Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours 3. Ability to participate in 42-day follow-up (patient has easy access to health unit)
Exclusion criteria
Exclusion criteria: 1. Weight 30 min) 6.2. Recent convulsions (1-2 within 24 h) 6.3. Altered consciousness (confusion, delirium, psychosis, coma) 6.4. Lethargy 6.5. Unable to drink or breast feed 6.6. Vomiting everything 6.7. Unable to stand/sit due to weakness 6.8. Severe anemia (Hb < 5.0 gm/dL) 6.9. Respiratory distress (labored breathing at rest) 6.10. Jaundice 7. Severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm). 8. Regular medication, which may interfere with antimalarial pharmacokinetic 9. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Risk of parasitological treatment failure (Early Treatment Failure (ETF) 2. Late Parasitological Failure (LPF) 3. Late Clinical Failure (LCF)) All assessed after 42 days of follow-up unadjusted and adjusted by genotyping to distinguish recrudescence from new infections. Risks will be estimated using the Kaplan-Meier product limit formula based on a modified intention-to-treat analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of fever (defined as both subjective fever in the previous 24 hours and measured axillary temperature greater than 37.5ºC) on follow-up days 1, 2, and 3 2. Prevalence of parasitemia (proportion of patients with malaria parasites in their blood) on follow-up days 1, 2 and 3 3. Parasite clearance time. Defined as the number (n) and the proportion (%) of patients with a positive parasite count on day 2 and 3 as well as the number (N) of patients evaluated on that day shall be estimated. The parasite clearance rate and initial parasite clearance lag phase duration shall be estimated by modelling the log (parasitemia) time profile using the PCT calculator 4. Change in mean hemoglobin from day 0 to 42 (or day of rescue therapy for patients classified as LCF or LPF), measured from blood samples 5. Prevalence of gametocytemia and gametocyte density in the blood on follow-up days 1, 2, 3, 7, 14, 21, 28, 35 and 42 6. Proportion of patients experiencing any serious adverse event in each treatment group during the 42-day follow-up period (both including and excluding patients classified as ETF or LCF, as recurrent malaria can be confounding) 7. Proportion of patients with adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy during follow up days. 8. Change in the prevalence of molecular markers in the blood, associated with drug resistance (proportion of patients who fail treatment with K 13 mutants) from day 0 to the day of recurrent parasitemia | — |
Countries
Uganda
Outcome results
None listed