Phase 3
N=1,271
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00403260 ↗Enrolled (actual)
1,271
Serious AEs
0.7%
Results posted
Sep 2021
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pyronaridine - artesunate (Drug); Mefloquine plus artesunate (Drug)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Oct 2008
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 | — |
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.
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). 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.