None listed
Conditions
Brief summary
Purpose of the study is to determine efficacy and safety of artemether -lumefantrine, and dihydroartemisinine-pipraquine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax in Buthitaung, Rakhine state, Myanmar. The study will be conducted during October 2019 to September 2020. Total 150 patients will be enrolled (, 50 falciparum malaria cases for artemether-lumefantrine trial, 50 falciparum malaria cases for dihyddroartemisinin-piperaquine trial and 50 vivax malaria cases for chloroquine trial. Clinical and parasitological parameters will be monitored over 28-days follow-up period for artemether-lumefantrine trial and chloroquine trial group, and 42 days for dihyddroartemisinin-piperaquine trial group to evaluate drug efficacy and safety
Interventions
To treat the confirmed Plasmodium falciparum malaria patients with artemether–lumefantrine; usual adult oral dose of 4 tabs (each tablet containing 20 mg artemether and 120 mg lumefantrine) twice daily for three days (a target dose 1.3/8 mg /kg twice daily for 3 days) or in dihydroartemisinin-piperaquine combination treatment - orally 3 tablets once (tablet containing 40mg dihydroartemisinin and 320 mg piperaquine phosphate ) per day for 3 days (target dose 2-2.4/16-19.2 mg/kg once a day for 3 d
To treat the confirmed Plasmodium falciparum malaria patients with artemether–lumefantrine; usual adult oral dose of 4 tabs (each tablet containing 20 mg artemether and 120 mg lumefantrine) twice daily for three days (a target dose 1.3/8 mg /kg twice daily for 3 days) or in dihydroartemisinin-piperaquine combination treatment - orally 3 tablets once (tablet containing 40mg dihydroartemisinin and 320 mg piperaquine phosphate ) per day for 3 days (target dose 2-2.4/16-19.2 mg/kg once a day for 3 days) will be given. Primaquine tablet (containing 7.5 mg ) will be given orally at the dose of 0.75 mg/kg as stat dose for all falciparum infected cases together with first dose of ACT(artemether-lumefantrine or dihydrortemisinin-piperaquine). For confirmed Plasmodium vivax infected cases, chloroquine tablet (containing 150 mg base) will be given orally at the dose of 10mg/kg for day1 and day2, and 5mg/kg on day3 to have a total dose 25mg base/kg and it will be followed by radical curative treatment with primaquine tablet orally at the dose of 0.25mg base/kg/day for 14 days. If there is G6PD deficiency determined by G6PD RDT, primaquine will not be given. Case recruitment will start with artemether-lumefantrine to get full sample size and it will be followed by dihydroartemesinin-piperaquine. To monitor the adherence of ACT and chloroquine, the first dose will be administered at health center under observation of Research Medical Officer, and the following doses will be monitored by malaria volunteer health worker by recollecting the empty blisters daily. Primaquine in vivax infected patients will not be monitored.
Sponsors
Ministry of Health and Sports
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
mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/µl asexual forms) or P. vivax detected by microscopy (parasitaemia more than equal to 250/µl asexual forms), or• presence of axillary temperature moret than or equal to 37.5 °C or history of fever during the past 24 hr, or ability to swallow oral medication, or ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule, or informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority, informed assent from any minor participant aged from 12 to age of majority years, and consent for pregnancy testing from female of child-bearing age (defined as age greater than 12 years and sexually active) and from their parent or guardian if under the age of majority years.
Exclusion criteria
presence of signs of severe falciparum malaria according to the definitions of WHO,, female aged from 12 years and age of majority, weight under 5 kg, haemoglobin less than 8 g/dl, mixed or mono-infection with another Plasmodium species detected by microscopy, presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm,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), Female patients who are sexually active within the age range of 12-17 year will be excluded, regular medication, which may interfere with antimalarial pharmacokinetics, history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and a positive pregnancy test or breastfeeding, unable to or unwilling to take a pregnancy test or contraceptive (for women of child-bearing age).
Outcome results
None listed