None listed
Conditions
Brief summary
Title: Efficacy and safety of artmether-lumefantrine in one site and dihydroartimisinine-pipraquin in three sites for the treatment of uncomplicated Plasmodium falciparum malaria. Purpose: To assess the efficacy of the current first and second line treatment policy. Objective: To assess the efficacy and safety of artmether-lumefantrine and dihydroartimisinine-pipraquine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Sennar (artemether-lumefantrine), and South Darfur, Blue Nile and Gadaref (dihydroartimisininne/pipraquine) Study Period: October2018 to April 2019. Study Design: It is a one arm prospective study. Patient population: Febrile patients aged six months and above, with confirmed uncomplicated P. falciparum infection. Unmarried females in child bearing age 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 per each antimalarial drug. Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28 days for artmether/lumefantrine efficacy or 42 days for dihydroartimisinine/pipraquine 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. Optional exploratory endpoints: Secondary endpoints: (i) The frequency and nature of adverse events and (ii) the molecular markers for artemisinin (k13) and piperaquine (plasmepsin 2) resistance.
Interventions
The study aims to evaluate the efficacy and safety of artemether-lumefantrine (20 mg/120 mg in each table) twice daily doses for three days in one site and dihydroartemisinin-piperaquine (40mg/320 mg) once daily for three days in three sites for the treatment of uncomplicated falciparum. For artemether-lumefantrine, the dose regimens 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
The study aims to evaluate the efficacy and safety of artemether-lumefantrine (20 mg/120 mg in each table) twice daily doses for three days in one site and dihydroartemisinin-piperaquine (40mg/320 mg) once daily for three days in three sites for the treatment of uncomplicated falciparum. For artemether-lumefantrine, the dose regimens 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. For dihydroartemisinin-piperaquine, 4mg/kg body weight (bw) dihydroartemisinin+18mg/kg bw piperaquine will be given. All treatments will be taken orally under direct supervision by the health worker. The patients treated with artemether-lumefantrine will be followedup for 28 days and those treated with dihydroartemisinin-piperaquine will be followe-up for 42 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 female minors (from 12 years) and unmarried females. 2. mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); 3. parasitaemia of 1000 to 100000 asexual parasite per microliter blood; 4. presence of axillary temperature egual or greater than 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 age of majority; 8. informed assent from any minor participant aged from 12 to below below age of majority (18 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