None listed
Conditions
Brief summary
Purpose of the study was 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 was conducted during June 2016 to December 2016. Total 199 patients were enrolled (, 70 falciparum malaria cases for artemether-lumefantrine trial, 71 falciparum malaria cases for dihyddroartemisinin-piperaquine trial and 57 vivax malaria cases for chloroquine trial. Clinical and parasitological parameters were 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
Treating malaria patients with standard dose and course of antimalarials as follow;
Artemether 2mg/Kg and lumefantrine 12 mg/Kg two times a day for three days course in one group (each tablet containing artemether 20 mg and lumefantrine 120mg)usually 2 tablets stat orally, another 2 tablets after 8 hrs on day 1, two tablets twice daily on day2 and 3.
Dihydroartemisinin 2-2.4 mg/Kg & piperaquine phosphate 16-19.2 mg/Kg combination on Day 0,1 & 2 in one group and were used for P. falciparum ca
Treating malaria patients with standard dose and course of antimalarials as follow; Artemether 2mg/Kg and lumefantrine 12 mg/Kg two times a day for three days course in one group (each tablet containing artemether 20 mg and lumefantrine 120mg)usually 2 tablets stat orally, another 2 tablets after 8 hrs on day 1, two tablets twice daily on day2 and 3. Dihydroartemisinin 2-2.4 mg/Kg & piperaquine phosphate 16-19.2 mg/Kg combination on Day 0,1 & 2 in one group and were used for P. falciparum cases.Each tablet containing 40mg dihydroartemisinin and 320 mg piperaquine phosphate was administered at the dosage of 3 tabs given daily for 3 days. Chloroquine 10 mg , 10 mg and 5 mg per Kg on day 0,1 and 2 days was given for P. vivax cases. Chloroquine containing 150mg base of chloroquine was given 4 tablets on day 1, and day 2, 2 tablets on day 3. Every first dose was given by directly observed treatment (DOT) by trained Medical Officer and following doses by malaria volunteers. To check the compliance, malaria volunteers visited the patient's home and recollected the empty blister cards. Artemether-lumefantrine trial was started to enroll all criteria matched falciparum cases up to proposed study sites and followed by Dihydroartemisinine-piperquine trial. Falciparum malaria case enrollment for artemether-lumefantrine took place first to get proposed sample size and case enrollment for dihydroartemisinine-piperquine. Vivax malaria case enrollment took place in parallel to falciparum.
Sponsors
Ministry of Health and Sports
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• age between 6 years and above ; • mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/µl asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms); • presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h; • ability to swallow oral medication; • ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and • informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
• presence of signs of severe falciparum malaria according to the definitions of WHO • 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 < 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); • 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