Malaria
Conditions
Interventions
Artesunate 100 and Amodiaquine 270 combination
Arthemeter 40 and lumefantrine 240 combination
Dihydroartemisinine 40mg and piperaquine 320 combination
Sponsors
MBUOMBOH Liwo Blaise Veranso
Professor TELEFO Phelix Bruno
Professor MBULLI Ali Innocent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? age, 6 months to 10 years; ? mono-infection with P. falciparum detected by microscopy; ? asexual parasite count of 1000–100 000/µl ; ? axillary temperature = 37.5 °C or history of fever during the 24 hours before recruitment; ? 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.
Exclusion criteria
Exclusion criteria: ? presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1); ? weight under 5 kg; ? haemoglobin < 8 g/dl; ? mixed or mono-infection with another Plasmodium species detected by microscopy; ? presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score; ? 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 medicine(s) being tested or used as alternative treatment(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early treatment failure •danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia; •parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; •parasitaemia on day 3 with axillary temperature = 37.5 ºC; •parasitaemia on day 3 = 25% of count on day 0. ;Late clinical failure •danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28/42 in patients who did not previously meet any of the criteria of early treatment failure; •presence of parasitaemia on any day between day 4 and day 28/42 with axillary temperature = 37.5 ºC or history of fever in patients who did not previously meet any of the criteria of early treatment failure. ;Late parasitological failure •presence of parasitaemia on any day between day 7 and day 28/42 with axillary temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure. ;Adequate clinical and parasitological response •absence of parasitaemia on day 28/42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse drug adverse events • Serious adverse events will be evaluated for severity(mild, moderate or severe) and relationship to the study drug(none, possible, probable or definite). | — |
Countries
Cameroon
Contacts
Public ContactTELEFO PHELIX BRUNO
Supervisor
Outcome results
None listed