Phase 3
Completed N=1,272
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
Source: ClinicalTrials.gov NCT00422084 ↗Enrolled (actual)
1,272
Serious AEs
0.4%
Results posted
Sep 2021
Primary outcomePrimary: PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 — 99.5; 99.2 percentage of subjects — p=0.578
◆ Published Evidence
Highly cited
143citations · ~9 / year
Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial.
Summary
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.
Linked Publications (4)
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Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial.
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Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials.
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Population Pharmacokinetics of Pyronaridine in Pediatric Malaria Patients.
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Pyronaridine-artesunate for treating uncomplicated Plasmodium falciparum malaria.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 |
99.5; 99.2 | 0.578 |
| SECONDARY PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 14 |
99.9; 100 | — |
| SECONDARY Crude ACPR (Non-PCR Corrected ACPR) on Day 14 and Day 28 |
100; 100; 98.9; 97.2 | — |
| SECONDARY Parasite Clearance Time |
23.9; 24.0 | — |
| SECONDARY Fever Clearance Time |
7.9; 8.0 | — |
| SECONDARY Percentage of Patients With Fever Clearance at Day 1, 2 and 3 |
88.7; 87.0; 99.0; 98.7; 99.5; 99.3 | — |
| SECONDARY Proportion of Patients With Parasite Clearance at Day 1, 2 and 3 |
68.1; 52.8; 98.1; 97.2; 99.5; 99.7 | — |
| SECONDARY Adverse Events and Clinically Significant Laboratory Results |
509; 241; 275; 123; 3; 2 | — |
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. 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, in accordance with local practice, 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 2.5 times the upper limit of normal range.
- Known significant renal impairment as indicated by serum creatinine >1.4 mg/dL.
Data sourced from ClinicalTrials.gov (NCT00422084) 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.