Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 6 months and above 2) With a positive blood smear for P. falciparum asexual parasitaemia with no other cause of the symptoms 3) Who meet the WHO clinical or laboratory criteria for severe malaria requiring parenteral therapy 3) Whose parents/caretakers provide written informed consent and are willing to participate in 42 day follow up
Exclusion criteria
Exclusion criteria: 1) Administration of any additional antimalarial drugs that are not study drugs within 72 hours before study enrolment and during the course of the study. 2) Emergence of any non-malarial febrile illness which may interfere with the classification of malaria treatment outcome 3) Movement away from the study area interfering with follow-up assessment 4) Patients with contraindications to taking the study drugs 5) Withdrawal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure unadjusted by genotyping | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment failure adjusted by genotyping;Time to event outcomes including: fever and parasite clearance times, coma recovery time, time to begin oral intake and time to sit up unsupported;Haemoglobin recovery on day 28;Adverse events | — |
Countries
Uganda
Contacts
CO-INVESTIGATOR