The primary objective of the study was to determine the PCR-APCR up to day 42 in children <60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®). Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.

NCT03768908

Conditions

1. Plasmodium Falciparum Malaria

Interventions

1. Drug: Artemether-lumefantrine
2. Drug: Artesunate + Amodiaquine

MeSH:Malaria Malaria, Falciparum

Proportions of single nucleotide polymorphisms at pfmdr1 Y86N and pfcrt K76T determined by established AluI restriction-based PCR-RFLP.. Inclusion Criteria: - Weight ≥5kg - No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2) - History of fever within 24 hours OR axillary temperature ≥ 37.5Cº - No other cause of fever is detectable - No severe malnutrition - Patient has parasite counts between 2000-200,000/ul (50-5000/200 white blood cells) - Guardian/Patient has understood the procedures of the study and is willing to participate - Patient able to come for stipulated follow up visits and has easy access to the Study Site Exclusion Criteria: General Danger Signs and Complications: - Not able to drink or breastfeed - Vomiting everything - Recent history of convulsions - Lethargic or unconscious - Unable to sit or stand (as appropriate for age) - History of allergy to test drugs - History of intake of any drugs other than paracetamol and aspirin within 3 days Signs of Severe Malaria: - Altered consciousness - Repeated convulsions - Inability of oral intake - Severe anaemia (Hb <5gm/dl) - Difficulty in breathing (pulmonary oedema, Respiratory Distress Syndrome) - Shock (small pulse, cold extremities) - Hypoglycaemia - Haemoglobinuria (dark coloured urine or Coca-Cola urine) - Kidney failure (little or no urine in a well-hydrated patient) - Jaundice (yellow colouring of eyes) - Hyperpyrexia (temperature above 39.5ºC) in combination with other signs - Hyperparasitaemia (more than 5% red blood cells parasitized or >200,000 parasites/µl) - Spontaneous bleeding (Disseminated Intravascular Coagulation) Inclusion Criteria: - Weight ≥5kg - No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2) - History of fever within 24 hours OR axillary temperature ≥ 37.5Cº - No other cause of fever is detectable - No severe malnutrition - Patient has parasite counts between 2000-200,000/ul (50-5000/200 white blood cells) - Guardian/Patient has understood the procedures of the study and is willing to participate - Patient able to come for stipulated follow up visits and has easy access to the Study Site Exclusion Criteria: General Danger Signs and Complications: - Not able to drink or breastfeed - Vomiting everything - Recent history of convulsions - Lethargic or unconscious - Unable to sit or stand (as appropriate for age) - History of allergy to test drugs - History of intake of any drugs other than paracetamol and aspirin within 3 days Signs of Severe Malaria: - Altered consciousness - Repeated convulsions - Inability of oral intake - Severe anaemia (Hb <5gm/dl) - Difficulty in breathing (pulmonary oedema, Respiratory Distress Syndrome) - Shock (small pulse, cold extremities) - Hypoglycaemia - Haemoglobinuria (dark coloured urine or Coca-Cola urine) - Kidney failure (little or no urine in a well-hydrated patient) - Jaundice (yellow colouring of eyes) - Hyperpyrexia (temperature above 39.5ºC) in combination with other signs - Hyperparasitaemia (more than 5% red blood cells parasitized or >200,000 parasites/µl) - Spontaneous bleeding (Disseminated Intravascular Coagulation) Plasmodium Falciparum Malaria Malaria Malaria, Falciparum All children in the right age group presenting with clinical signs of malaria at the study site were considered possible study subjects. --- Y86N ---

The pfmdr1 Y86N and pfcrt K76T genes' Single Nucleotide Proteins (SNPs) analysis was done according to established AluI restriction-based PCR-RFLP protocols. --- Y86N ---