Malaria
Conditions
Interventions
pyronaridine plus artesunate
Sponsors
CERMEL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age between 6 months to 12 years; • mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); • parasitaemia of 1 000–200 000/µl asexual forms; • presence of axillary temperature = 37.5 °C or oral, rectal, or tympanic temperature of = 38 °C or history of fever during the past 24 h; • 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; • informed consent from a parent or guardian in the case of children aged less than age of majority; • Written informed and assent consent by participants and caretakers as applicable.
Exclusion criteria
Exclusion criteria: • presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1); • hemoglobin < 8 g/dl; • mixed or mono-infection with another Plasmodium species detected by microscopy; • presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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 any of the medicines being tested or used as alternative treatment(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines [13]. Thus, all patients will be classified as having early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) or an adequate clinical and parasitological response (ACPR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
Countries
Gabon
Contacts
Public ContactJean claude Dejon Agobe
CERMEL
Outcome results
None listed