Phase 3
N=456
Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00440999 ↗Enrolled (actual)
456
Serious AEs
0.4%
Results posted
Sep 2021
Primary outcome: Primary: Crude Cure Rate on Day 14 — 217; 209; 75; 73 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pyronaridine artesunate (Drug); Chloroquine (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crude Cure Rate on Day 14 |
217; 209; 75; 73; 33; 33 | — |
| SECONDARY Crude Cure Rate on Days 21 and 28. |
99.5; 99.5; 97.1; 98.0 | — |
| SECONDARY Parasite Clearance Time |
23.1; 32.0 | — |
| SECONDARY Fever Clearance Time |
15.8; 23.8 | — |
| SECONDARY Percentage of Subjects With Parasite Clearance on Days 1, 2, and 3 |
71.6; 30.6; 99.5; 88.0; 100.0; 96.7 | — |
| SECONDARY Percentage of Subjects With Fever Clearance on Days 1, 2, and 3 |
78.6; 58.4; 89.9; 88.3; 97.0; 97.4 | — |
| SECONDARY Number of Participants With Adverse Events |
92; 72; 27; 23; 2; 0 | — |
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 adults with acute, uncomplicated Plasmodium vivax malaria.
Eligibility 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. 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 Criteria
- Presence of a mixed Plasmodium infection.
- Presence of other clinical condition requiring hospitalization.
- Presence of significant anaemia, as defined by Hb 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.
Data sourced from ClinicalTrials.gov (NCT00440999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.