NCT02389439

Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria

Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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).

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Pyronaridine-artesunate

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2015-03-17
• Last updated: 2018-09-20

Locations

3 sites across 1 country: Cambodia