Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This study is a prospective, single arm, open-labelled clinical trial. The total number
subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days.
Dosing will be according to the body weight.
All patients will have a blood smear examined daily during the first week by microscopy until
parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and
sexual stages). A negative blood slide will be defined as parasite count negative per 1000
WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h
after the initial blood smear.
Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21,
28, 35 and 42).