Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00440999
• Date of registration: 26/02/2007
• Prospective Registration: Yes
• Primary sponsor: Medicines for Malaria Venture
• Public title: Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
• Scientific 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
• Date of first enrolment: March 2007
• Target sample size: 456
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00440999
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Cambodia, India, Indonesia, Thailand

Contacts

• Name: Isabelle Borghini Fuhrer, PhD
• Affiliation: Medicines for Malaria Venture

Key inclusion & exclusion 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.



Age minimum: 3 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Chloroquine

Drug: Pyronaridine artesunate

Primary Outcome(s)

Incidence of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities.

Cure rate on Day 14. [Time Frame: Day 14]

Secondary Outcome(s)

Fever clearance time.

Cure rate on Days 21 and 28. [Time Frame: Day 21 and 28]

Proportion of patients who have cleared fever on days 1, 2 and 3.

Parasite clearance time.

Proportion of patients who have cleared parasites on days 1, 2 and 3.

Secondary ID(s)

SP-C-006-06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shin Poong Pharmaceuticals