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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403260
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : April 30, 2020
Shin Poong Pharmaceuticals
Information provided by (Responsible Party):
Medicines for Malaria Venture

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Pyronaridine artesunate Drug: Mefloquine plus artesunate Phase 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 1
Pyronaridine artesunate (180:60 mg tablets)
Drug: Pyronaridine artesunate
once a day for 3 days
Other Name: Pyramax

Active Comparator: 2
Mefloquine plus artesunate
Drug: Mefloquine plus artesunate
once a day for 3 days

Primary Outcome Measures :
  1. PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28 [ Time Frame: Day 28 ]
  2. Treatment success or failures will be classified according to WHO Guidelines 2005 [ Time Frame: 28 days ]
  3. Incidence and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities [ Time Frame: Day 28 and Day 42 ]

Secondary Outcome Measures :
  1. PCR-corrected ACPR on Day 14 [ Time Frame: Day 14 ]
  2. Crude ACPR on Days 14 and 28 [ Time Frame: Day 14 and 28 ]
  3. Parasite Clearance Time [ Time Frame: Day 7 ]
  4. Fever Clearance Time [ Time Frame: Day 7 ]
  5. Parasite clearance at Day 1, 2 and 3 [ Time Frame: Days 1, 2 and 3 ]
  6. Fever clearance at Day 1, 2 and 3 [ Time Frame: Days 1, 2 and 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403260

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Burkina Faso
RAOTAP2/Centre Muraz
Bobo Dioulasso, Houet Province, Burkina Faso, 01 BP390
Pailin Referral Hospital
Pailin, Pailin Province, Cambodia
Côte D'Ivoire
Institut Pasteur
Abidjan, Côte D'Ivoire
Wentlock District Hospital
Mangalore, India
Bagamoyo Research and Training Centre of Ifakara Health Institute
Bagamoyo, Tanzania
MaeLamad District Hospital
Mae Ramat, Tak Province, Thailand
MaeSod General Hospital
Mae Sot, Tak Province, Thailand
Hanoi, Commune Xy, Vietnam
Choray Hospital, Dak O
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
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Study Director: Isabelle Borghini-Fuhrer, PhD Medicines for Malaria Venture
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medicines for Malaria Venture Identifier: NCT00403260    
Other Study ID Numbers: SP-C-004-06
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Keywords provided by Medicines for Malaria Venture:
P falciparum
Additional relevant MeSH terms:
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Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents