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Pyronaridine Artesunate (3:1) Versus Mefloquine Artesunate in P Falciparum Malaria Patients

Information source: Medicines for Malaria Venture
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria

Intervention: Pyronaridine artesunate (Drug); Mefloquine plus artesunate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Medicines for Malaria Venture

Official(s) and/or principal investigator(s):
Isabelle Borghini-Fuhrer, PhD, Study Director, Affiliation: Medicines for Malaria Venture


The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180: 60 mg) with that of the combination of mefloquine plus artesunate in children and adults with uncomplicated P falciparum malaria.

Clinical Details

Official title: A Phase III Comparative, Open-Label, Randomised, Multi-Centre, Clinical Study to Assess the Safety and Efficacy of Fixed Dose Formulation Oral Pyronaridine Artesunate (180:60 mg Tablet) Versus Mefloquine (250 mg Tablet) Plus Artesunate (100 mg Tablet) in Children and Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28

Treatment success or failures will be classified according to WHO Guidelines 2005

Incidence and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities

Secondary outcome:

PCR-corrected ACPR on Day 14

Crude ACPR on Days 14 and 28

Parasite Clearance Time

Fever Clearance Time

Parasite clearance at Day 1, 2 and 3

Fever clearance at Day 1, 2 and 3

Detailed description: Plasmodium falciparum malaria kills over one million people and results in up to 500 million cases annually, affecting mainly young children and pregnant women. Artemisinin-based combination therapies (ACT) 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 antischizonticidal 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 parasitaemia with a three-day regimen, thereby improving compliance and reducing the risk of recrudescence through the slower elimination of pyronaridine.


Minimum age: 3 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female patients between the age of 3 and 60 years, inclusive.

- Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

- Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

1. Fever, as defined by axillary/tympanic temperature ≥ 37. 5°C or oral/rectal temperature ≥ 38°C, or documented history of fever in the previous 24 hours and, 2. Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/µl of blood

- Written informed consent provided by patient and/or parent/guardian/spouse.

- Ability to swallow oral medication.

Exclusion Criteria:

- Patients with signs and symptoms of severe/complicated malaria requiring parenteral

treatment according to the World Health Organization Criteria 2000.

- Mixed Plasmodium infection.

- Severe vomiting or severe diarrhoea.

- Known history or evidence of clinically significant disorders.

- Presence of significant anaemia, as defined by Hb < 8 g/dL.

- Presence of febrile conditions caused by diseases other than malaria.

- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine,

mefloquine or artesunate or other artemisinins.

- Use of any other antimalarial agent within 2 weeks prior to start of the study as

evidenced by positive urine test.

- Female patients of child-bearing potential must be neither pregnant (as demonstrated

by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.

- Presence of significant renal or hepatic impairment.

Locations and Contacts

Institut Pasteur, Abidjan, Côte D'Ivoire

Wentlock District Hospital, Mangalore, India

Bagamoyo Research and Training Centre of Ifakara Health Institute, Bagamoyo, Tanzania

Choray Hospital, Dak O, Ho Chi Minh City, Vietnam

NIMPE, Hanoi, Commune Xy, Vietnam

RAOTAP2/Centre Muraz, Bobo Dioulasso, Houet Province 01 BP390, Burkina Faso

Pailin Referral Hospital, Pailin, Pailin Province, Cambodia

MaeLamad District Hospital, MaeLamad, Tak Province, Thailand

MaeSod General Hospital, MaeSod, Tak Province, Thailand

Additional Information

Medicines for Malaria Venture

Shin Poong Pharmaceuticals

Starting date: January 2007
Last updated: January 21, 2009

Page last updated: August 23, 2015

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