Phase 3
Completed N=1,271
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Falciparum Malaria
Source: ClinicalTrials.gov NCT00403260 ↗
Enrolled (actual)
1,271
Serious AEs
0.7%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 — 99.2; 98.1 percentage of subjects — p=0.106
◆ Published Evidence
Highly cited
110citations · ~8 / year
Pyronaridine-artesunate versus mefloquine plus artesunate for malaria.
Summary
The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India and Africa.
Linked Publications (3)
-
Pyronaridine-artesunate versus mefloquine plus artesunate for malaria.
-
Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials.
-
Population Pharmacokinetics of Pyronaridine in Pediatric Malaria Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 |
99.2; 98.1 | 0.106 |
| SECONDARY PCR-corrected ACPR on Day 14 |
99.9; 99.5 | — |
| SECONDARY Crude ACPR on Days 14 and 28 |
99.9; 99.5; 98.7; 96.7 | — |
| SECONDARY Parasite Clearance Time |
31.7; 32.0 | — |
| SECONDARY Fever Clearance Time |
15.9; 16.0 | — |
| SECONDARY Parasite Clearance at Day 1, 2 and 3 |
38.5; 31.6; 83.8; 79.8; 91.5; 90.5 | — |
| SECONDARY Fever Clearance at Day 1, 2 and 3 |
78.5; 78.9; 95.9; 96.2; 99.2; 98.4 | — |
| SECONDARY Adverse Events and Clinically Significant Laboratory Results |
389; 190; 153; 94; 6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients between the ages 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. falciparum mono-infection confirmed by:
- Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or documented history of fever in the previous 24 hours and,
- Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/µl of blood
- Written informed consent provided by patient and/or parent/guardian/spouse.
- Ability to swallow oral medication.
Exclusion Criteria
- Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
- Mixed Plasmodium infection.
- Severe vomiting or severe diarrhoea.
- Known history or evidence of clinically significant disorders.
- Presence of significant anaemia, as defined by Hb <8 g/dL.
- Presence of febrile conditions caused by diseases other than malaria.
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, mefloquine or artesunate or other artemisinins.
- Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by positive urine test.
- 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.
- Presence of significant renal or hepatic impairment.
- Receipt of an investigational drug within the past 4 weeks.
- Known active Hepatitis A IgM, Hepatitis B surface antigen or Hepatitis C antibody.
- Known seropositive HIV antibody.
- Previous participation in any clinical study with PA.
Data sourced from ClinicalTrials.gov (NCT00403260) and the linked publication. 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. Informational only — not medical advice.