None listed
Conditions
Brief summary
To study the efficacy of antimalarial drugs in Myanmar
Interventions
For Plasmodium falciparum:
The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orally in a twice daily dose for three days, as follows: One tablet to those weighing 5-14kg; two tablets to children with 15-24 kg and three tablets to children weighing 25-35 kg. Four tablets to those over 35kg. The full course of treatment for all study patients consists of 6-doses given twice daily.
For Plasmodium falciparum: The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orally in a twice daily dose for three days, as follows: One tablet to those weighing 5-14kg; two tablets to children with 15-24 kg and three tablets to children weighing 25-35 kg. Four tablets to those over 35kg. The full course of treatment for all study patients consists of 6-doses given twice daily. The next 80 patients will be administered dihydroartemisinin-piperaquine. A fixed dose of 40 mg dihydroartemisinin and 320 mg piperaquine phosphate) will be administered orally as a weight per dose regimen of 2.25 and 18 mg/kg per dose of dihydroartemisinin and piperaquine phosphate. The medicine will be given a daily dose over three days. For plasmodium vivax: Chloroquine phosphate 150 mg base per tablet will be given a total dose of 25 mg per kg. body weight as: 10 mg per kg body weight for days 1 and 2 while 5 mg per kg body weight on day 3. All drug administration is supervised over the period of three days.
Sponsors
Department of Medical Research (Upper Myanmar)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria are. ge between 6 years inclusive and above; mono-infection with plasmodium falciparum detected by microscopy (parasitaemia of 500-100,000/microlitre asexual forms) or plasmodium vivax detected by microscopy (parasitaemia great than 250/microlitre asexual forms); presence of axillary equal to or great than 37.5 degrees celcius 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 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 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); 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); a positive pregnancy test or breastfeeding for falciparum malaria; and unable to or unwilling to take a pregnancy test or contraceptives.
Outcome results
None listed