Efficacy of antimalarials (Artemether/Lumefantrine and Dihydroartemisinine/Piperaquine) used in Burkina Faso for the treatment of malaria in childre
- Conditions
- Malaria
- Registration Number
- PACTR201708002499311
- Lead Sponsor
- Improving Malaria Care (IMC Project)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 720
Age, 6¿59 months,
Mono-infection with P. falciparum detected by microscopy;
Asexual parasite count of 2000¿200 000/¿l
Axillary temperature ¿ 37.5 °C or history of fever during the previous two weeks;
Hemoglogin ¿ 8g/dl
Ability to swallow oral medication;
Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule;
Informed consent from a parent or guardian in the case of children
Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
Body weight less than 5 kg;
Presence of severe malnutrition (defined as a child whose growth standard 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 withdehydration) 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)
Known individual or familly history of clinically significant prolonged QTc or subite death
Previous particpation to malaria vaccine trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adequate clinical and parasitological response at day 28 PCR-corrected.;Late treatment failure;Early treatment failure
- Secondary Outcome Measures
Name Time Method Adequate clinical and parasitological response at day 42, PCR-corrected.;Fever clearance;Parasite clearance;Nature and incidence of adverse events