None listed
Conditions
Brief summary
Therapeutic efficacy testing of artemether lumefantrine and artesunate+sulfadoxine/pyrimethamine combination therapies for the treatment of uncomplicated P. falciparum infections in Mali.
Interventions
Assessing the efficacy and safety of artemether-lumefantrine combination therapy for the treatment of uncomplicated P. falciparum infections in Mali. Drug is to be administered orally using the following regimen according to body mass: twice a day for three days - 20:120mg - less than 15kg - 1 tablet, 15 - 25 kg - 2 tablets, 25 - 35 kg - 3 tablets, more than 35kg - 4 tablets
Sponsors
Malaria Research and Training Center
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients above 6 months of age; 2. Malaria positive P. falciparum mono-infection; 3. Parasite density of 1,000-100,000 parasites; 4. 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. 7. Informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO in children (aged 6- 59 months); 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 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). 7. Female adolescents (12-18 years), pregnant or breast-feeding women;
Outcome results
None listed