None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Afgoye site and Plasmodium vivax in Bosaso site, Somalia Purpose: To assess the efficacy of current first-line treatment. Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated P. falciparum and P. vivax, Somalia. Study Sites: Afgoye for P. falciparum and Bosaso for P. vivax. Study Period: From July 2018 to April 2019 Study Design: One arm prospective study. Patient population: Febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum or P. vivax infection. Female minors aged 12-17 years and unmarried females aged 18 years and above will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. Sample Size: A total of 88 patients will be enrolled in each site. Treatment(s) and follow-up: Artemether+lumefantrine twice daily for 3 days will be evaluated. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. 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 will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: • The frequency and nature of adverse events • proportion of polymorphism of molecular markers for artemisinin resistance (K13)
Interventions
The objective of the study is to assess the efficacy and safety of artemether+lumefantrine (20 mg/120 mg in each table) twice daily doses for three days for the treatment of uncomplicated falciparum (Afgoye site) and vivax (Bosaso site) malaria. The dose regimens for both Plasmodium and vivax infection will be 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
The objective of the study is to assess the efficacy and safety of artemether+lumefantrine (20 mg/120 mg in each table) twice daily doses for three days for the treatment of uncomplicated falciparum (Afgoye site) and vivax (Bosaso site) malaria. The dose regimens for both Plasmodium and vivax infection will be 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
World Health Organization Count Office Somalia
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age between 6 months and 60 years with the exception of 12-17years old female minors and unmarried females 18 years and above; 2. mono-infection with P. falciparum (Afgoye site) or P. vivax (Bosaso site) confirmed by positive blood smear (i.e. no mixed infection); 3. parasitaemia of 500 - 200000 per microliter asexual forms; 4. presence of axillary temperature greater or equal to 37.5 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 age of majority years; and 9. consent for pregnancy testing from female of child-bearing age (defined as age below 12 years and sexually active) and from their parent or guardian if under the age of majority years.
Exclusion criteria
1. presence of general danger signs in children aged under 12 years or signs of severe falciparum or vivax malaria according to the definitions of WHO; 2. female aged from 12 years and age of majority; 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 who has a mid-upper arm circumference below 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