Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase III Multi-Centre, Randomised, Double-Blind, Double-Dummy, Comparative Clinical Study to Assess the Safety and Efficacy of a Fixed-Dose Formulation of Oral Pyronaridine Artesunate (180:60 mg Tablet) Versus Chloroquine (155 mg Tablet), in Children and Adult Patients With Acute Plasmodium Vivax Malaria|
- Cure rate on Day 14. [ Time Frame: Day 14 ]
- Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.
- Cure rate on Days 21 and 28. [ Time Frame: Day 21 and 28 ]
- Parasite clearance time.
- Fever clearance time.
- Proportion of patients who have cleared parasites on days 1, 2 and 3.
- Proportion of patients who have cleared fever on days 1, 2 and 3.
|Study Start Date:||March 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Artemisinin-based combination therapies (ACTs) are considered today by WHO to be the best anti-malarials in terms of efficacy and lower propensity to resistance. Pyronaridine artesunate is a new ACT in development to treat acute uncomplicated malaria. Pyronaridine and artesunate are antimalarial agents with a history of clinical use both separately and in combination with other drugs. Each drug has powerful blood schizonticidal actions. The aim of a fixed dose combination of pyronaridine and artesunate in the treatment of uncomplicated acute malaria is to provide rapid reduction in parasitemia with once-daily three-day regimen, thereby improving compliance and reducing the risk of recrudescence through the slower elimination of pyronaridine.Importantly, there is a need for new drugs that are efficacious against both P. falciparum and P. vivax, because in areas where both species exist and health systems are undersourced, it is often not possible to distinguish between the two species at the initial diagnosis.
|Pailin Referral Hospital|
|Pailin, Pailin Province, Cambodia|
|Wentlock District Hospital|
|RSUD TC Hillers|
|Maumere, Nusa Tenggara Timur, Indonesia, 86113|
|MaeLamad District Hospital|
|MaeLamad, Tak Province, Thailand|
|MaeSod General Hospital|
|MaeSod, Tak Province, Thailand|
|Study Director:||Isabelle Borghini Fuhrer, PhD||Medicines for Malaria Venture|