Last Updated: 16/06/2015
Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria
Objectives
Containment of artemisinin resistance in western Cambodia and the Cambodia-Thailand border area is critical for malaria control and elimination efforts both locally and globally. Given the urgent need for effective antimalarial therapies in Cambodia, current efficacy data on pyronaridine-artesunate as an alternative first-line treatment for uncomplicated P. falciparum malaria in this region were required.
The primary objective of this study was to assess the therapeutic efficacy of pyronaridine-artesunate against uncomplicated P. falciparum malaria in an area of artemisinin resistance in western Cambodia.
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).
ClinicalTrials.gov Identifier: NCT02389439
| Study Type : | Interventional (Clinical Trial) |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
Mar 2015 — Jun 2016
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