Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum and vivax malaria in Eritrea in 2024
Ministry of Health
480 participants
Oct 21, 2024
Interventional
Conditions
Summary
Efficacy of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum or Plasmodium vivax was assessed in three sentinel sites (Akordat, Goluj, Shambuko and Tokombia) in Eritrea in 2024. The study enrolled 484 patients between 21 October 2024 and 16 January 2025. 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 Criteria9
- age between 6 months to and above;
- mono-infection with P. falciparum or P. vivax confirmed by positive blood smear (i.e. no mixed infection);
- parasitaemia of 250-200, 000 per µl asexual forms;
- presence of axillary or tympanic temperature equal to or greater 37.5 centigrade degrees 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 the patient or from a parent or guardian in the case of children aged less than 18;
- informed assent from any minor participant aged from 12 to 18 years; and
- consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) and from their parent or guardian if under the age of 18.
Exclusion Criteria10
- presence of general danger signs in children aged under 12 years or signs of severe malaria according to the definitions of WHO protocol https://cdn.who.int/media/docs/default-source/malaria/template-protocol-for-tet-en.docx?sfvrsn=e9dceb7e_2);
- weight under 5 kg;
- haemoglobin below 8 g per dl;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference above 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);
- a positive pregnancy test or breastfeeding; and
- unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age greater 12 years and sexually active).
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Interventions
The study aims to evaluate efficacy and safety of artemether-lumefantrine in the treatment of treatment of uncomplicated Plasmodium falciparum or vivax infection. Tablets containing 20 mg artemether and 120 mg lumefantrine in each tablet was given twice daily for three consecutive days based the recommended weight bands: 1 tablet to those weighing 5 to 14 kg.; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. For children, tablets were crushed and added to water in spoon and given to them. All treatments was given orally under direct supervision by the study nurse. Patients were followed up for 28 days.
Locations(1)
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ACTRN12626000256370