None listed
Conditions
Brief summary
Title: To assess the efficacy and safety of Artemether-Lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Blue Nile, Kassale and Sennar state. Study Period: September/2017 to March 2018. Study Design: This surveillance study was a one arm prospective study. Patient population: Febrile patients aged above six months, with confirmed uncomplicated P. falciparum infection. Female minors aged 12-17 years and unmarried females in child-bearing age were excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. Sample Size: A total of 88 patients was enrolled at each site. Clinical and parasitological parameters were monitored over a 28 days follow-up period to evaluate drug efficacy of artemether 20mg /lumefantrine120mg six-dose course over 3 days according to weight bands (1 tab: 5-14kg, 2 tabs: 15-24kg, 3 tabs: 25-34kg and 4 tabs: greater than or equal to 35kg). All treatment doses were administered under direct observation. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence was distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: (i) The frequency and nature of adverse events and (ii) the polymorphism of molecular markers for artemisinin (K13), piperaquine (amplification of plasmepsin 2) and mefloquine (amplification of mdr-1)
Interventions
This was a one arm prospective study to assess the efficacy and safety of artemether-lumefantrine (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) given twice daily for three days according to the recommended weight bands as follows: 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
This was a one arm prospective study to assess the efficacy and safety of artemether-lumefantrine (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) given twice daily for three days according to the recommended weight bands as follows: 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. The patients were followed up 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 above six months excluding unmarried females of child bearing age (from 12 years). 2. mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); 3. parasitaemia of 1000–100000 asexual parasite per microliter forms; 4. presence of axillary temperature equal or greater than 37.5 degrees centigrade 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 age of majority; 8. informed assent from any minor participant aged from 12 to 17 years; and 9. consent for pregnancy testing from married female of child-bearing age
Exclusion criteria
1. presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO; 2. unmarried female in the child bearing age 3. weight under 5 kg; 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 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. 10. Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age (defined as age above 12 years and sexually active)
Outcome results
None listed