None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefantrine and dihydroartemisinin+piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in different sentinel sites in Sudan Purpose: To assess the efficacy and safety of the current second line treatment policy as well as a new antimalarial drug to support updating the national policy; Objective: To assess the efficacy and safety of artemether+lumefantrine and dihydroartemisin+piperaquine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Geneina and Kerink, (West Dafur), Sinnar, Gadaref, and Kassala. Study Period: December 2016 to April 2017. Study Design: One arm prospective study. Patient population: Febrile patients aged six months 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 (20mg)/lumefantrine (120mg) of six-dose course over 3 days according to weight bands (1 tab: 5 to 14kg, 2 tabs: 15 to 24kg, 3 tabs: 25 to 34kg and 4 tabs: greater than or equal to 35kg) or Dihydroartemisin/pipepraquine (4mg/kg bw dihydroartemisin and 18mg/kg bw piperaquine once a day for three days. Clinical and parasitological parameters will be monitored over a 28 days (for artemether+lumefantrine) or 42 days (for dihydroartemisin+piperaquine) follow-up period to evaluate drug efficacy and safety. 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. To determine the molecular markers for artemisinin (K13) resistance.
Interventions
To assess the efficacy and safety of artemether-lumefantrine (given twice a day for 3 days) and dihydroartemisinin+piperaquine (given daily for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses of artemether-lumefantrine (20/120) will be administered according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14kg; 2 tablets for 15 to 24 kg;3 tablets for 25 to34 kg and 4 tablets for equal or greater than 35 kg. For dihydroartemisinin+piperaquine
To assess the efficacy and safety of artemether-lumefantrine (given twice a day for 3 days) and dihydroartemisinin+piperaquine (given daily for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses of artemether-lumefantrine (20/120) will be administered according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14kg; 2 tablets for 15 to 24 kg;3 tablets for 25 to34 kg and 4 tablets for equal or greater than 35 kg. For dihydroartemisinin+piperaquine, 4 mg/kg DHA and 18 mg/kg piperaquine once a day for 3 days. The treatment will be given in tablets by oral under direct supervision. Eligible subjects will be treated for three days and followed up for 28 days for artemether+lumefantrine or dihydroartemisinin+pipearquine for 42 days..
Sponsors
Federal 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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age above six months with the exception of 12-17 years old female minors and unmarried females above 18 years and above; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000-100,000/microL asexual forms; 4. presence of axillary temperature greater or equal to 37.5 degrees C 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; and 7. Informed consent from the patient or from a parent or guardian in the case of children. 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 who has a mid-upper arm circumference below 110 mm); 5. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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); and 8. a positive pregnancy test or breastfeeding. 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