Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 6 months or above, had an axillary temperature = 37.5 °C at presentation or history of fever during the last 24 hours, a positive P. falciparum mono-infection parasitemia of 1,000 to 100,000 asexual forms/ul, ability to swallow oral medication, ability and willingness to comply with the study protocol and visit schedule for the duration of the study, written informed consent from the patient or from the parent or guardian for enrolled children
Exclusion criteria
Exclusion criteria: presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO , mixed or mono-infection with another Plasmodium species detected by microscopy, positive pregnancy test, severe malnutrition, febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases, regular medication, which may interfere with anti-malarial treatment, 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 |
|---|---|
| The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and nature of adverse events | — |
Countries
Senegal
Contacts
Project manager