Status:
COMPLETED
Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
Lead Sponsor:
Medicines for Malaria Venture
Collaborating Sponsors:
Shin Poong Pharmaceuticals
Conditions:
Malaria
Eligibility:
All Genders
3-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and...
Detailed Description
This is a multi-centre, randomised, double-blind, double-dummy, parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of pyronaridine/artesunate (ie, PP/AS \...
Eligibility Criteria
Inclusion
- 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. 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).
- 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.
- Ability to swallow oral medication.
- Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.
Exclusion
- Presence of a mixed Plasmodium infection.
- Presence of other clinical condition requiring hospitalization.
- Presence of significant anaemia, as defined by Hb \<8 g/dL.
- Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval ≥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).
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
- Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
- Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
- Known seropositive HIV antibody.
- Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
- Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
- Have received any investigational drug within the past 4 weeks.
- Liver function tests (AST/ALT levels) \>2.5 times the upper limit of normal range.
- Known significant renal impairment as indicated by serum creatinine levels of \>1.4 mg/dL.
- 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.
- Previous participation in the present clinical trial with PA.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00440999
Start Date
March 1 2007
End Date
September 1 2008
Last Update
November 2 2021
Active Locations (5)
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1
Pailin Referral Hospital
Pailin, Pailin, Cambodia
2
Wentlock District Hospital
Mangalore, India
3
RSUD TC Hillers
Maumere, Nusa Tenggara Timur, Indonesia, 86113
4
MaeLamad District Hospital
Mae Ramat, Changwat Tak, Thailand