Efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in South Sudan.
Ministry of Health
440 participants
Jan 3, 2024
Interventional
Conditions
Summary
Efficacy and safety of artesunate-amodiaquine (ASAQ) or artemether-lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum in South Sudan were assessed. ASAQ was assessed in Juba, Bor and Wau sites and AL in Yambio and Juba) between January 2024 and January 2025. The study enrolled 402 patients. Primary endpoint was the proportion of patients with treatment failure and secondary endpoints were proportions of K13 mutation and day 3 positive cases.
Eligibility
Inclusion Criteria7
- age between 6 and 59 months.
- mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- parasitaemia of 1000-200, 000 asexual stages per microliter µl ;
- presence of axillary or tympanic temperature greater or equal 37.5 degree centigrade or history of fever during the past 24 h;
- ability to swallow oral medication.
- ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
- informed consent from a parent or guardian of children.
Exclusion Criteria8
- presence of general danger signs in children aged or signs of severe falciparum malaria according to the definitions of WHO 2009 protocol;
- weight under 5 kg;
- haemoglobin level below 8 grams per deciliter;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition defined as a child aged between 6-60 months who has a mid-upper arm circumference < 115 mm);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
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Interventions
This was a single-arm prospective study designed to assess the efficacy and safety of artesunate–amodiaquine and artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum infection. For the artemether–lumefantrine group, tablets containing 20 mg of artemether and 120 mg of lumefantrine were administered twice daily for three consecutive days, according to recommended weight bands: 1 tablet for patients weighing 5–14 kg, 2 tablets for 15–24 kg, 3 tablets for 25–34 kg, and 4 tablets for those weighing =35 kg. The total target dose ranges were 5–24 mg/kg body weight (bw) for artemether and 29–144 mg/kg bw for lumefantrine. For the artesunate–amodiaquine group, dosing was also weight-based as follows: one tablet of 25/67.5 mg for patients weighing 4.5 to <9 kg; one tablet of 50/135 mg for 9 to <18 kg; one tablet of 100/270 mg for 18 to <36 kg; and two tablets of 100/270 mg for those weighing =36 kg. The target daily doses were approximately 4 mg/kg bw of artesunate and 10 mg/kg bw of amodiaquine. All treatment doses were administered orally under direct supervision by a study nurse. Patients were followed for 28 days. For children, tablets were crushed, mixed with water, and administered a spoon. Participants were reimbursed for transportation costs to attend all scheduled visits to the health center. At sites evaluating both treatment regimens, patients were sequentially enrolled: initially into the artesunate–amodiaquine group (first-line treatment) until the target sample size (n = 88) was reached, followed by enrollment into the artemether–lumefantrine group until a similar sample size (n = 88) was achieved
Locations(1)
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ACTRN12626000495325