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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Tasanh Health Centre, Battambang
Battambang, Cambodia
Referral hospital (Pailin)
Pailin, Cambodia
Promoy Health Centre (Pursat)
Pursat, Cambodia
result of PCR
Time frame: 42 day
hepatic biological values
the hepatic biological values will be measured which are AST,ALT,albumin and total bilirubin
Time frame: at day 0, 3,7 and day 28
eosinophil count
Time frame: at day 0, 3, 7 and day 28
K13 and pfmdr1 of P falciparum resistance
Time frame: at day 0, 3, 7 and day 28
numbers of patients with a positive malaria slide 72 hours after treatment initiation
Time frame: 72 hours
fever clearance time
the time taken for tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
Time frame: 24 hours
Number of patient with reinfection and recrudescences
Time frame: over 42 days
PCR uncorrected ACPR
PCR uncorrected ACPR at 28 days or 42 days for P. falciparum, P. falciparum and mixed infections in Pailin
Time frame: at 28 days or 42 days
PCR corrected ACPR
PCR corrected ACPR at 28 days or for P. falciparum, P. vivax and mixed infections and at 42 days for P. falciparum and mixed infections
Time frame: at 28 days and 42 days
Gametocyte carriage rates
Time frame: at day 0, 3, 7 day 28
gametocyte clearance times
Time frame: at day 0, 3, 7 and day28
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