Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
Information source: Medicines for Malaria Venture
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Pyronaridine artesunate (Drug); Chloroquine (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 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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Cure rate on Day 14.Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.
Secondary outcome: Cure rate on Days 21 and 28.Parasite clearance time. Fever clearance time. Proportion of patients who have cleared parasites on days 1, 2 and 3. Proportion of patients who have cleared fever on days 1, 2 and 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Wentlock District Hospital, Mangalore, India
RSUD TC Hillers, Maumere, Nusa Tenggara Timur 86113, Indonesia
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: March 2007
Last updated: January 21, 2009
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