Health Condition 1: null- Male or female aged 6 months to 65 years old with Acute uncomplicated P falciparum malaria
Conditions
Interventions
Intervention1: Artemether-lumefantrine AL
plus
Amodiaquine AQ
Primaquine PQ
: Day 1 AL Oral tab 3.4/24 mg/kg/day plus AQ 10mg /kg/day
Day 2 AL Oral tab 3.4/24 mg/kg/day plus
AQ 10 mg/kg/day
Day 3
Sponsors
UK Department for International Development DFID
Eligibility
Inclusion criteria
Inclusion criteria: Acute uncomplicated P. falciparum malaria confirmed by positive blood smear with asexual forms of P. falciparum Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, determined on a thin or thick blood film Fever defined as > 37.5°C tympanic temperature or a history of fever within the last 24 hours Written informed consent (by parent/guardian in case of chil-dren) Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study
Exclusion criteria
Exclusion criteria: Signs of severe/complicated malaria Haematocrit Acute illness other than malaria requiring treatment For females: pregnancy, breast feeding Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days Antimalarial therapy in past Two months Previous splenectomy Documented or claimed history of cardiac conduction prob-lems Earlier participation within the TRACII trial or another trial in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endpoint 42 day PCR corrected efficacy defined as adequate clinical and parasitolog-ical response (ACPR). WHO definition: absence of parasitaemia at day 42 irrespective of axillary temperature and without previously meeting any of the WHO criteria for early or late treatment failure, or late parasitological failure.Timepoint: 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasite clearance half-life assessed by microscopy Fever clearance time Incidence of adverse events and serious adverse events by study arms within the first 42 days. Incidence of prolongation of the Qtc-interval above 500 ms or 30ms above baseline values. Prevalence of Kelch13 mutations Timepoint: 42 days | — |
Countries
Bangladesh, Cambodia, Democratic Republic of the Congo, India, Myanmar, Thailand, Viet Nam
Contacts
Public ContactDr Anup Anvikar
National Institute of Malaria Research
Outcome results
None listed