Efficacy and parasite clearance time with artemether-lumefantrine for uncomplicated falciparum malaria in children of Nchelenge District, Zambia
- Conditions
- Malaria
- Registration Number
- PACTR201905783261453
- Lead Sponsor
- Macha Research Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Age between 6 months and 5 years (i.e. up to 59 months of age)
Mono-infection with P. falciparum detected by microscopy
Parasitaemia of 2,000 to 200,000 /µl asexual forms
Presence of axillary or tympanic temperature = 37.5 °C or oral or rectal temperature of = 38 °C, or history of
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
Written informed consent from a parent or guardian
Presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO as adapted to the clinic setting
Mixed or mono-infection with another Plasmodium species detected by microscopy
Presence of severe malnutrition defined as a child whose growth (wt for age) is below –3 Z-score
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 artemether-lumefantrine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method