Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
Condition: Malaria
MeSH terms: Malaria; Malaria, Vivax
Intervention: Pyronaridine - artesunate; Chloroquine
Intervention description: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.; Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
Intervention MeSH terms: Artesunate; Chloroquine; Pyronaridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 3 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Artemisinin-based combination therapy (ACT); Pyramax; Pyronaridine artesunate; Chloroquine; Children; Adults; Plasmodium vivax; Republic of Korea

Summary:

      The primary objective of this clinical 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 (P. vivax) malaria
    

Eligibility 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:

               1. 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,

               2. Positive microscopy of P. vivax with parasite density ≥250/ μL 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) >2.5 times the upper limit of normal range.

         13. Known significant renal impairment as indicated by serum creatinine levels of >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.