None listed
Conditions
Brief summary
To study the efficacy of antimalarial drugs in Myanmar
Interventions
The patients will be administered artesunate in oral tablet form (50 mg of artesunate per tablet,) at a dose of 4mg/kg/day for 7 days. Each dose administration will be observed and recorded.
Sponsors
Clinical Research Unit ( Malaria), Defense Services General Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
male and female age older than 18 years; mono-infection with P. falciparum detected by microscopy (parasitaemia of 10 000-100 000/microlitres asexual forms or P. vivax detected by microscopy (parasitaemia greater than 250/microlitres asexual forms); presence of axillary greater than or equal to 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
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 febrile conditions due to diseases other than malaria (e.g. 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 contraceptives (for women of child-bearing age); patients presenting with splenectomy.
Outcome results
None listed