Malaria
Conditions
Interventions
AL arm
Sponsors
Department of States
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Participants must meet all of the following criteria to be enrolled: Age: 6–59 months Weight: = 5 kg Confirmed infection: Mono-infection with Plasmodium falciparum Parasite density: 2,000–200,000 asexual parasites/µL of blood Fever: Axillary temperature = 37.5 °C or history of fever within the last 24 hours Hemoglobin level: = 8.0 g/dL Ability to take oral medication Willingness and ability to comply with study procedures and follow-up schedule Accessibility: Resides within reach of the health facility and able to return for follow-up visits Informed consent: Written permission provided by parent or legal guardian Summary: Eligible participants are young children with confirmed uncomplicated P. falciparum malaria, meeting clinical, parasitological, and logistical criteria to ensure safe treatment and reliable follow-up
Exclusion criteria
Exclusion criteria: Exclusion Criteria Participants will be excluded if any of the following conditions are present at enrollment (Day 0): Signs of severe or complicated malaria (danger signs) Pneumonia or bronchopneumonia Severe malnutrition (Z-score < -3) Recent antimalarial or relevant antibiotic use (within the past 14 days; e.g., cotrimoxazole, tetracycline, doxycycline) Mixed malaria infection (infection with more than one Plasmodium species) History of hypersensitivity or allergy to artemether–lumefantrine or related medications Summary: Children are excluded if they have severe disease, confounding illnesses, recent treatment exposure, or conditions that may compromise safety or interpretation of treatment outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Type: Efficacy outcome (clinical and parasitological) Measure: Adequate Clinical and Parasitological Response (ACPR) at Day 28 Includes classification into: Early Treatment Failure (ETF) Late Clinical Failure (LCF) Late Parasitological Failure (LPF) Reported as both PCR-uncorrected and PCR-corrected efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will assess the following secondary outcomes: Safety outcomes Incidence and type of adverse events (AEs) and serious adverse events (SAEs) during the 28-day follow-up period Molecular resistance markers Frequency of genetic polymorphisms associated with antimalarial resistance, including: pfk13 (artemisinin resistance) pfmdr1, pfcrt, dhfr, dhps hrp2/hrp3 gene deletions Proportion of baseline samples with hrp2 and/or hrp3 deletions, which may affect performance of HRP2-based rapid diagnostic tests | — |
Countries
Sierra Leone
Contacts
Public ContactAbdul Mac Falama
National Malaria Control Program
Outcome results
None listed