None listed
Conditions
Brief summary
Title: Efficacy and safety of Artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea. Purpose: To assess the efficacy a new antimalarial drug to support updating the national policy in introducing the drug as a second line treatment for uncomplicated malaria. Objective: To assess the efficacy and safety of Artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Tokombia, Shambuko, Goluj, Akordat and Ghindae. Study Period: 4 months (September-December, 2017). Study Design: This surveillance study is a one-arm 28-day in-vivo prospective study. Patient population: Febrile patients aged between 6 months and above, with confirmed uncomplicated P. falciparum infection. Sample Size: We will enrol 88 patients per site to reach a sample size of 440. Treatment(s) and follow-up: Clinical and parasitological parameters was monitored over a 28-day follow-up period to evaluate drug efficacy of Artemther-lumefantrine (artemether 20 mg/lumeanine 120mg) twice daily for 3 days. 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: The frequency and nature of adverse events. Optional exploratory endpoints: to determine the polymorphism of molecular markers for artemisinin resistance
Interventions
The objective of the study was to assess the efficacy and safety of artemether+lumefantrine (20 mg/120 mg in each tablet) twice daily doses for three days for the treatment of uncomplicated falciparum malaria. The dose was calculated based on 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. All treatments will be taken orally under direct supervision by the health wo
The objective of the study was to assess the efficacy and safety of artemether+lumefantrine (20 mg/120 mg in each tablet) twice daily doses for three days for the treatment of uncomplicated falciparum malaria. The dose was calculated based on 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. All treatments will be taken orally under direct supervision by the health worker and will be followed up for 28 days.
Sponsors
Ministry of Health, Eritrea
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. age 6 months and above; 2. mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); 3. parasitaemia of 250-200 000 asexual forms per microliter; 4. presence of axillary temperature greater or equal to 37.5 degree 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 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 above 12 years and sexually active) and from their parent or guardian if under the age of 18 years.
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. weight under 5 kg; 3. haemoglobin below 8 g per deciliter; 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 who has a mid-upper arm circumference < 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 above 12 years and sexually active).
Outcome results
None listed