None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Johar and Bosaso sites, Somalia. Purpose: To assess the efficacy of a potential second line treatment policy. Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Johar and Bosaso sites. Study Period: From August 2017 to April 2018 Study Design: One arm prospective study. Patient population: Febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum 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: 1. The frequency and nature of adverse events 2. 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 malaria. The dose 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 healt
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 malaria. The dose 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
Ministry of Health and Human Services, Federal Government
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 detected by microscopy; 3. parasitaemia of 500 - 200000/µl asexual forms; 4. presence of axillary or tympanic 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 years; 8. informed assent from any minor participant aged from 12 to age of majority years; and 9. consent for pregnancy testing from married female of 18 years and above.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; 2. weight under 5 kg; 3. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. presence of severe malnutrition (defined as a child aged 6-60 months who has a mid-upper arm circumference below 115 mm); 5. 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); 6. regular medication, which may interfere with antimalarial pharmacokinetics; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 8. a positive pregnancy test or breastfeeding of married women aged 18 years and above; and 9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
Outcome results
None listed