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
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.
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 28Treatment 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 14Crude 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
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
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