Pyronaridine Artesunate (3:1) Versus Mefloquine Artesunate in P Falciparum Malaria Patients - Full Text View

Sponsors and Collaborators:	Medicines for Malaria Venture Shin Poong Pharmaceuticals
Information provided by:	Medicines for Malaria Venture
ClinicalTrials.gov Identifier:	NCT00403260

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 III

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Mefloquine Mefloquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	1269
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pyronaridine artesunate (180:60 mg tablets)	Drug: Pyronaridine artesunate once a day for 3 days
2: Active Comparator 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

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

Locations

Burkina Faso, Houet Province
RAOTAP2/Centre Muraz	Recruiting
Bobo Dioulasso, Houet Province, Burkina Faso, 01 BP390
Contact: Robert T Guiguemdé, MD (226) 20 97 28 24 rguiguemde@yahoo.fr
Contact: Halidou Tinto, PhD
Principal Investigator: Robert T Guiguemdé, MD
Sub-Investigator: Halidou Tinto, PhD
Cambodia, Pailin Province
Pailin Referral Hospital	Recruiting
Pailin, Pailin Province, Cambodia
Contact: Duong Socheat, MD (855-12) 815 950 socheatd@cnm.gov.kh
Principal Investigator: Duong Socheat, Dr
India
Wentlock District Hospital	Recruiting
Mangalore, India
Contact: Neena Valecha, MD 91-11-23943743 neenavalecha@gmail.com
Principal Investigator: B H Krishnamoorthy Rao, Dr
Principal Investigator: Neena Valecha, Dr
Thailand, Tak Province
MaeSod General Hospital	Recruiting
MaeSod, Tak Province, Thailand
Contact: Ronnatrai Ruangweerayut, MD 665 554 2336 ronnatrai@yahoo.com
Principal Investigator: Ronnatrai Ruangveerayuth, Dr
MaeLamad District Hospital	Recruiting
MaeLamad, Tak Province, Thailand
Contact: Ronnatrai Ruangweerayut, MD 665 554 2336 ronnatrai@yahoo.com
Principal Investigator: Ronnatrai Ruangveerayuth, Dr
Sub-Investigator: Chirapong Uthaisin, Dr
Vietnam
Choray Hospital, Dak O	Recruiting
Ho Chi Minh City, Vietnam
Contact: Nong Thi Tien, MD +84 553 5031
Principal Investigator: Tran Quang Binh, Dr
Vietnam, Commune Xy
NIMPE	Recruiting
Hanoi, Commune Xy, Vietnam
Contact: Trang Quang Binh, MD +84 854 0099 binhtq@hcm.vnn.vn
Principal Investigator: Nong Thi Tien, Dr

Sponsors and Collaborators

Medicines for Malaria Venture

Shin Poong Pharmaceuticals

Investigators

Study Director:

Isabelle Borghini-Fuhrer, PhD

Medicines for Malaria Venture

More Information

Medicines for Malaria Venture This link exits the ClinicalTrials.gov site

Shin Poong Pharmaceuticals This link exits the ClinicalTrials.gov site

Responsible Party:	Medicines for Malaria Venture ( Isabelle Borghini Fuhrer )
Study ID Numbers:	SP-C-004-06
Study First Received:	November 22, 2006
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00403260
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

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Pyronaridine
Parasitic Diseases

Malaria
Mefloquine
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009