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

This study has been completed.
Sponsor:
Collaborator:
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT00403260
First received: November 22, 2006
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Malaria
Drug: Pyronaridine artesunate
Drug: Mefloquine plus artesunate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medicines for Malaria Venture:

Primary Outcome Measures:
  • PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Treatment success or failures will be classified according to WHO Guidelines 2005 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PCR-corrected ACPR on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Crude ACPR on Days 14 and 28 [ Time Frame: Day 14 and 28 ] [ Designated as safety issue: No ]
  • Parasite Clearance Time [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Fever Clearance Time [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Parasite clearance at Day 1, 2 and 3 [ Time Frame: Days 1, 2 and 3 ] [ Designated as safety issue: No ]
  • Fever clearance at Day 1, 2 and 3 [ Time Frame: Days 1, 2 and 3 ] [ Designated as safety issue: No ]

Enrollment: 1269
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403260

Locations
Burkina Faso
RAOTAP2/Centre Muraz
Bobo Dioulasso, Houet Province, Burkina Faso, 01 BP390
Cambodia
Pailin Referral Hospital
Pailin, Pailin Province, Cambodia
Côte D'Ivoire
Institut Pasteur
Abidjan, Côte D'Ivoire
India
Wentlock District Hospital
Mangalore, India
Tanzania
Bagamoyo Research and Training Centre of Ifakara Health Institute
Bagamoyo, Tanzania
Thailand
MaeLamad District Hospital
MaeLamad, Tak Province, Thailand
MaeSod General Hospital
MaeSod, Tak Province, Thailand
Vietnam
NIMPE
Hanoi, Commune Xy, Vietnam
Choray Hospital, Dak O
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
Investigators
Study Director: Isabelle Borghini-Fuhrer, PhD Medicines for Malaria Venture
  More Information

Additional Information:
No publications provided by Medicines for Malaria Venture

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Isabelle Borghini Fuhrer, Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT00403260     History of Changes
Other Study ID Numbers: SP-C-004-06
Study First Received: November 22, 2006
Last Updated: January 21, 2009
Health Authority: Cambodia: Ministry of Health
India: Ministry of Health
Vietnam: Ministry of Health
Thailand: Ministry of Public Health
Burkina Faso: Ministry of Health

Keywords provided by Medicines for Malaria Venture:
malaria
ACT
P falciparum
pyronaridine
artesunate

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Pyronaridine
Mefloquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on October 02, 2014