Phase 2
Completed N=60
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Uncomplicated Plasmodium Falciparum Malaria
Source: ClinicalTrials.gov NCT00331136 ↗
Enrolled (actual)
60
Serious AEs
3.4%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 — 11; 13; 15; 14 Participants
Summary
The purpose of this study is to evaluate three dose levels of a combination tablet and a fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute uncomplicated falciparum malaria in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 |
11; 13; 15; 14 | — |
| SECONDARY Parasite Clearance Time |
16.4; 16.1; 8.1; 8.3 | — |
| SECONDARY Treatment Success or Failure |
11; 13; 15; 14; 0; 0 | — |
| SECONDARY Fever Clearance Time |
8.2; 8.6; 8.2; 8.2 | — |
| SECONDARY Number of Patients With PCR-corrected ACPR on Day 14 |
11; 13; 15; 14 | — |
| SECONDARY Number of Patients With Parasite Clearance at Day 1, 2 and 3 |
10; 11; 14; 14; 1; 2 | — |
| SECONDARY Number of Subjects With P. Falciparum Gametocytes During the Trial |
2; 0; 1; 1; 3; 1 | — |
| SECONDARY Percentage of Patients With Fever Clearance at Day 1, 2 and 3 |
3; 5; 3; 1; 0; 0 | — |
| SECONDARY Crude ACPR on Day 14, 28 and 42 |
11; 13; 15; 14; 11; 10 | — |
| SECONDARY Number of Patients With PCR-corrected ACPR on Day 42 |
10; 8; 15; 13 | — |
Eligibility Criteria
Inclusion Criteria
Patients presenting with symptoms of acute uncomplicated falciparum malaria with the following inclusion criteria:
- Male or female children, being between 2 and 14 years of age inclusive
- Weight between 10 and 40 kg inclusive
- Written informed consent, in accordance to local practice, provided by parent/guardian. If the parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations. Where possible, parent assent will be sought
- Absence of severe malnutrition (defined as mid upper arm circumference 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, acute QTc interval greater or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
- Presence of febrile conditions caused by diseases other than malaria
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
- Use of any other antimalarial treatment within 2 weeks prior to start of the study as confirmed by Lignin test and Saker Solomon urine test
- For females of childbearing potential, positive urine pregnancy test or lactating
- Use of an investigational drug within the past 8 weeks
- Known active Hep A immunoglobulin, Hep B surface antigen, or Hep C antibody
- Known seropositive HIV antibody
- Liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] levels) >3 times the upper limit of normal
- Known significant renal impairment as indicated by a serum creatinine ≥2 mg/dL
- Previous participation in this clinical study
Data sourced from ClinicalTrials.gov (NCT00331136). 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.