None listed
Conditions
Brief summary
The efficacy of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria was evaluated in two sentinel sites (Kobeni and Timbedra) in Mauritania in 2023. A total of 132 patients were enrolled between August and October 2023. The primary endpoint was the PCR-corrected cure rate, while secondary endpoints included the proportion of K13 mutations and the proportion of patients remaining parasitemic on day 3. This study aims to confirm that a commonly used malaria treatment still cures at least 9 out of 10 patients within 28 days in these areas and to check for early signs that the malaria parasite may be becoming resistant to the treatment.
Interventions
A single-arm prospective study was conducted to evaluate the efficacy and safety of artemether-lumefantrine at two sites in Mauritania. Artemether-lumefantrine (20 mg artemether/120 mg lumefantrine per tablet) was administered twice daily for three consecutive days according to the recommended weight bands: one tablet for patients weighing 5–14 kg, two tablets for 15–24 kg, three tablets for 25–34 kg, and four tablets for those weighing equal or greater than 35 kg. All doses were administered or
A single-arm prospective study was conducted to evaluate the efficacy and safety of artemether-lumefantrine at two sites in Mauritania. Artemether-lumefantrine (20 mg artemether/120 mg lumefantrine per tablet) was administered twice daily for three consecutive days according to the recommended weight bands: one tablet for patients weighing 5–14 kg, two tablets for 15–24 kg, three tablets for 25–34 kg, and four tablets for those weighing equal or greater than 35 kg. All doses were administered orally under the direct supervision of the study team. Patients were monitored clinically and parasitologically for 28 days.
Sponsors
Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. age between 6 months to and above; 2. mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); 3. parasitaemia of 250-200, 000 per µl asexual forms; 4. presence of axillary or tympanic temperature equal to or greater 37.5 centigrade degrees or history of fever during the past 24 h; 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18; 8. informed assent from any minor participant aged from 12 to 18 years; and 9. 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 criteria
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); 2. weight under 5 kg; 3. haemoglobin below 8 g per dl; 4. mixed or mono-infection with another Plasmodium species detected by microscopy; 5. 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). 6. 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); 7. regular medication, which may interfere with antimalarial pharmacokinetics; 8. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 9. a positive pregnancy test or breastfeeding; and 10. 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).
Outcome results
None listed