To detect artesunate resistance in uncomplicated Plasmodium falciparum malaria patients
- Conditions
- Health Condition 1: null- Uncomplicated falciparum Malaria
- Registration Number
- CTRI/2016/05/006964
- Lead Sponsor
- Department for International Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1800
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
Signs of severe/complicated malaria
Haematocrit < 25% or haemoglobin (Hb) < 8 g/dL at enrollment
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Parasite reduction rates and ratios at 24 and 48 hours by microscopy and quantitative PCR <br/ ><br>Time for parasite count to fall to 50%, 90% and 99% of initial parasite density <br/ ><br>Fever clearance time <br/ ><br>Proportion of patients with gametocytemia before, during and after treatment with artesunate, assessed at admission, on days 3, 7 and 14 <br/ ><br>Parasite molecular markers of drug resistanceTimepoint: 28 days follow up