Uncomplicated P. falciparum malaria infection Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
All subjects will receive treatment with artemether-lumefantrine (standard protocol). Patients will be followed up daily until day 7 and then weekly until 42 days.
Sponsors
Medicines for Malaria Venture (MMV) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged greater than 1 year 2. Fever (axillary, 37.5ºC) on admission, or reported history of fever within the last 72 hours (3 days) 3. Willingness to participate in particular to stay at the hospital for the first 7 days 4. Full written informed consent (signed) provided by themselves or by attending relatives 5. Signed pre-consent if patient was referred from a district hospital or dispensary 6. Willing to stay under close medical supervision at the hospital for the study duration of at 7 days, and willingness to participate weekly until the 6th week (42 days follow-up)
Exclusion criteria
Exclusion criteria: 1. Pregnancy: all females (aged 12 - 50 years) are required to have a "negative" pregnancy test (urine) or are currently using an acceptable method of contraception 2. Lactating mother 3. Intake of anti-malarial drugs for the last 3 days (reported on admission, urine samples for confirmation) 4. Mixed malaria infection on admission, i.e. P. falciparum and any other Plasmodium species 5. A previous history of intolerance or hypersensitivity to the study drugs artemether-lumefantrine or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin and lumefantrine-like compounds 6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness 7. Symptoms of severe vomiting 8. Signs or symptoms of severe malaria (World Health Organization [WHO] 2003) 9. Unable to follow the protocol 10. Age of 12 months and below
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parasite clearance time, assessed daily after until day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early treatment failure, measured by malaria symptoms present on day 3 after treatment start 2. Late treatment failure, measured by malaria symptoms on any follow-up after day 7 3. Late parasitological failure, measured by parasite present on any follow-up after day 7 | — |
Countries
Laos
Outcome results
None listed