Health Condition 1: null- Uncomplicated falciparum Malaria
Conditions
Interventions
Intervention1: Artesunate tablets: Artesuante 4mg per kg body weight Oral on Day0 Artesuante 4mg per kg body weight Oral on Day1 Artesuante 4mg per kg body weight Oral on Day2 followed by full course
Sponsors
Department for International Development
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: 10,000 to 100,000/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 legally acceptable representative in case of children) Willingness and ability of the patients/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, lactating Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days History of allergy or known contraindication to artemisinins, or to the ACT to be used at the site Previous splenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within one year the worldwide study is expected to produce a map of the geographical extent, prevalence and severity of artemisinin resistance, focused mainly in the known epicentre (Southeast Asia (SEA), but also with detailed results from two sentinel sites in Africa. During the above period only one patient could be enrolled at the study site, hence additional 2 sites have been added.Timepoint: 28 days follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasite reduction rates and ratios at 24 and 48 hours by microscopy and quantitative PCR Time for parasite count to fall to 50%, 90% and 99% of initial parasite density Fever clearance time Proportion of patients with gametocytemia before, during and after treatment with artesunate, assessed at admission, on days 3, 7 and 14 Parasite molecular markers of drug resistanceTimepoint: 28 days follow up | — |
Countries
Bangladesh, Cambodia, China, India, Kenya, Lao People's Democratic Republic, Myanmar, Nigeria, Thailand, Viet Nam
Contacts
Public ContactNeelima Mishra
National Institute of Malaria Research
Outcome results
None listed