None listed
Conditions
Brief summary
Therapeutic Efficacy Testing of artemether-lumefantrine for the treatment of uncomplicated plasmodium falciparum infection in mainland Tanzania
Interventions
Evaluating the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in Tanzania. Drug will be administered orally using a 6-dose regimen of artemether-lumefantrine (a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) twice a day for 3 days. (Patient weighing 5-14kg - one tablet, patients weighing 15-24kg - two tablets, patients weighing 25-35kg - 3 tablets).
Sponsors
Ministry of Health of Tanzania
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 10 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 6- months-10 years. 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of greater than or equal to 250/microlitre asexual forms; 4. presence of axillary temperature greater than or equal to 37.5 degrees celsius or history of fever during the past 24 hours 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 parent or guardian of children.
Exclusion criteria
1. presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO; 2. mixed or mono-infection with another Plasmodium species detected by microscopy; 3. 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 of less than 110 mm); 4. 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); 5. regular medication, which may interfere with antimalarial pharmacokinetics; 6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
Outcome results
None listed