se of triple combination for falciparum malaria
- Conditions
- Health Condition 1: null- Male or female aged 6 months to 65 years old with Acute uncomplicated P falciparum malaria
- Registration Number
- CTRI/2017/09/009594
- Lead Sponsor
- K Department for International Development DFID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Signs of severe/complicated malaria
Haematocrit < 25% or Hb < 8 g/dL at enrollment
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Parasite clearance half-life assessed by microscopy <br/ ><br>Fever clearance time <br/ ><br>Incidence of adverse events and serious adverse events by study arms within the first 42 days. <br/ ><br>Incidence of prolongation of the Qtc-interval above 500 ms or 30ms above baseline values. <br/ ><br>Prevalence of Kelch13 mutations <br/ ><br>Timepoint: 42 days