Phase 2 N=60 Treatment

Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria

Uncomplicated Plasmodium Falciparum Malaria

Bottom Line

View on ClinicalTrials.gov: NCT00331136 ↗

Enrolled (actual)

Serious AEs

3.4%

Results posted

Nov 2021

Primary outcome: Primary: Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28 — 11; 13; 15; 14 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pyronaridine-Artesunate (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Medicines for Malaria Venture
Primary completion: Dec 2006

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	—

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.

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

View full record on ClinicalTrials.gov →

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.