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Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria

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: NCT00440999
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : January 22, 2009
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Pyronaridine artesunate Drug: Chloroquine Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2008

Primary Outcome Measures :
  1. Cure rate on Day 14. [ Time Frame: Day 14 ]
  2. Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.

Secondary Outcome Measures :
  1. Cure rate on Days 21 and 28. [ Time Frame: Day 21 and 28 ]
  2. Parasite clearance time.
  3. Fever clearance time.
  4. Proportion of patients who have cleared parasites on days 1, 2 and 3.
  5. Proportion of patients who have cleared fever on 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:

  1. Male or female patients between the age of 3 and 60 years, inclusive.
  2. Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.
  3. Presence of acute uncomplicated P. vivax mono-infection confirmed by:

    • Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
    • Positive microscopy of P. vivax with parasite density ≥250/ mcL of blood (including at least 50% of asexual parasites)
  4. Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
  5. Ability to swallow oral medication.
  6. Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.

Exclusion Criteria:

  1. Presence of a mixed Plasmodium infection.
  2. Presence of other clinical condition requiring hospitalization.
  3. Presence of significant anaemia, as defined by Hb < 8 g/dL.
  4. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).
  5. Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
  6. Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
  7. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
  8. Known seropositive HIV antibody.
  9. Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
  10. Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
  11. Have received any investigational drug within the past 4 weeks.
  12. Liver function tests (AST/ALT levels) more than 2.5 times the upper limit of normal range.
  13. Known significant renal impairment as indicated by serum creatinine levels of more than 1.4 mg/dL.
  14. 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.
  15. Previous participation in the present clinical trial with pyronaridine artesunate.

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): NCT00440999

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Pailin Referral Hospital
Pailin, Pailin Province, Cambodia
Wentlock District Hospital
Mangalore, India
RSUD TC Hillers
Maumere, Nusa Tenggara Timur, Indonesia, 86113
MaeLamad District Hospital
MaeLamad, Tak Province, Thailand
MaeSod General Hospital
MaeSod, Tak Province, Thailand
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):
Layout table for additonal information Identifier: NCT00440999    
Other Study ID Numbers: SP-C-006-06
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009
Keywords provided by Medicines for Malaria Venture:
P vivax
Additional relevant MeSH terms:
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Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Antirheumatic Agents