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This study compared the effectiveness and safety of the drug combinations Artesunate-amodiaquine and Artemether-Lumefantrine for treating malaria in children in Yaoundé. It enrolled children aged 6 months to 120 months with microscopically confirmed uncomplicated P. falciparum malaria. The study was conducted in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Children of either gender, aged 6 months to 120 months will be recruited. * Acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density within the range 1000 to 200000 parasites/μl. * Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours. * Able to ingest tablets orally (either suspended in water or uncrushed with food). * Willing to participate in the study with written informed consent from parent/guardian. * Willing and able to attend the clinic on stipulated regular follow-up visits. Exclusion Criteria: * Mixed with another Plasmodium species detected by microscopy. * Children who are currently suffering or had the following within the last 2 months: tuberculosis, HIV, schistosomiasis, diabetes mellitus, cardiovascular disease, gout, rheumatoid arthritis, underlying chronic hepatic or renal disease, hypoglycaemia, jaundice, respiratory distress, and other inflammatory related diseases. * Signs/symptoms indicating severe/complicated malaria" according to WHO criteria (WHO definition) such as: Not able to drink or breast feed. Persistent vomiting (\>2 episodes within previous 24 hours). Convulsions (\>1 episode within previous 24 hours). Lethargic/unconscious. Severe anaemia (haemoglobin \< 5 g/dl). * Serious gastrointestinal disease. * Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below -3 z-score (W/H \< 70%) or has symmetrical edema involving at least the feet or has a mid-upper arm circumference \< 115 mm). * Regular medication, which may interfere with anti-malarial pharmacokinetics. * History of hypersensitivity reactions or contraindications to any of the medicine (s) being tested or used as alternative treatment (s). * Individuals who have taken part in anti-malarial efficacy and safety studies in the last 3 months. * Participants who have taken anti-malarial drugs in the last one month.