None listed
Conditions
Brief summary
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in patients 6 months and above in Yemen was evaluated. The treatment was given under direct supervision and clinical and parasitological parameters were monitored for 28 days to establish proportion of patients with PCR corrected treatment failure, frequency of adverse events and mutations in K13 gene on day 0 samples.
Interventions
This was a single arm prospective study to evaluate the efficacy and safety of artemether-lumefantrine. Artemether-lumefantrine tablets (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) was given two times daily for three days according to 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. The total target dose ranges were 5-24 mg/kg body weight (bw)of artemether
This was a single arm prospective study to evaluate the efficacy and safety of artemether-lumefantrine. Artemether-lumefantrine tablets (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) was given two times daily for three days according to 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. The total target dose ranges were 5-24 mg/kg body weight (bw)of artemether and 29-144 mg/kg bw of lumefantrine. All treatments was given orally under direct supervision by the health worker and patients were followed up for 28 days.Tablets were crushed and added to water in spoon and given to the child.
Sponsors
The Ministry of Public Health and Population
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
• age between 6 months and above, excluding female minors 12-17 years old and unmarried females aged 18 years and above; • mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); • parasitaemia of 500-200000 per micrometer asexual forms; • presence of axillary temperature greater or equal 37.5 degrees 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 the patient or from a parent or guardian in the case of children aged less than 18 years; • informed assent from any minor participant aged from 12 to age of majority years; and • consent for pregnancy testing from married female aged 18n years and above.
Exclusion criteria
• presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO; • female aged from 12 years and below 18 years; • weight under 5 kg; • haemoglobin below 8 g 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 below 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 married aged 18 years and above.
Outcome results
None listed