Malaria
Conditions
Interventions
Artemisinin based combination therapy
Sponsors
Noguchi Memorial Institute for Medical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age between 6 months and 9 years - mono-infection with P. falciparum detected by microscopy - asexual parasitaemia of 1,000 – 250,000/µl - presence of axillary temperature = 37.5oC or history of fever during the past 24 hours - ability to swallow oral medications - Parent/guardian giving consent and willing to comply with the study protocol for the duration of the study and to comply with the study visit schedule.
Exclusion criteria
Exclusion criteria: - presence of general danger signs or signs of severe falciparum malaria - mixed or mono-infection with another Plasmodium species detected by microscopy - presence of severe acute malnutrition (defined as presence of oedema of both feet or severe wasting: weight-for-length/height < -3 SD) - 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, and - history of hypersensitivity reactions or contraindication to any of the medicines being tested (i.e., AL, AS-AQ, AP, and DHAP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic efficacy according to WHO guidelines | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasitaemia;Incidence of Adverse events;Changes in Haemoglobin concentration;Prevalence of molecular markers of antimalarial drug resistance;Blood levels of lumefantrine | — |
Countries
Ghana
Contacts
Public ContactGriselda Osae Amoako
Noguchi Memorial Institute for Medical Research
Outcome results
None listed