Phase 3
Completed N=535
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
Source: ClinicalTrials.gov NCT00541385 ↗Enrolled (actual)
535
Serious AEs
0.2%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Participants With PCR-Corrected ACPR on Day 28 — 97.6; 98.8 percentage of cured subjects — p=<0.0001
◆ Published Evidence
Established
90citations · ~6 / year
Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial.
Summary
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%.
Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine [AL]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.
Linked Publications (4)
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Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled 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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Safety and efficacy of pyronaridine-artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With PCR-Corrected ACPR on Day 28 |
97.6; 98.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With PCR-Corrected ACPR on Day 14 |
100.0; 100.0 | — |
| SECONDARY Crude ACPR (Non-PCR Corrected ACPR) (Crude Cure Rate) on Day 14 and Day 28 |
100; 100; 90.2; 89.2 | — |
| SECONDARY Parasite Clearance Time |
24.1; 24.2 | — |
| SECONDARY Fever Clearance Time |
8.1; 8.1 | — |
| SECONDARY Proportion of Subjects With Cleared Parasites on Days 1, 2, and 3 |
49.9; 43.7; 95.5; 95.2; 97.0; 98.8 | — |
| SECONDARY Proportion of Subjects With Fever Cleared on Days 1, 2, and 3 |
87.1; 81.0; 98.5; 96.8; 99.6; 98.4 | — |
| SECONDARY Number of Subjects With ≥1 Adverse Event |
285; 143; 132; 80; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≤12 years of age.
- Body weight ≥ 5 kg and 3 times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as ≥3 watery stools per day.
- Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval ≥450 milliseconds), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including recent head trauma).
- Presence of significant anaemia, as defined by Hb 2.5 times upper limit of normal range.
- Known significant renal impairment as indicated by serum creatinine of >1.4 mg/dL.
- Previous participation in any clinical study with pyronaridine artesunate.
Data sourced from ClinicalTrials.gov (NCT00541385) 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.