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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate three dose levels of a combination of pyronaridine and artesunate for the treatment of uncomplicated falciparum malaria in children.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicines for Malaria Venture
• Collaborators: Institute of Tropical Medicine, University of Tuebingen; Shin Poong Pharmaceuticals
• Treatments: Artemisinins; Artesunate; Pyronaridine

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 <110mm)

• Presence of acute symptomatic uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only (i.e. no mixed infection) plus measured temperature of ≥37.5°C (depending on method of measurement as below) or history of fever within the past 24 hours :

• the acceptable range is between 1,000 and 200,000 asexual parasite count/μl of blood and

• axillary/tympanic temperature of ≥37.5°C or oral/rectal temperature of ≥38.0°C

Exclusion Criteria:

• Patients with signs and symptoms of severe/complicated malaria requiring parenteral antimalarial treatment according to the World Health Organization Criteria 2000

• Mixed Plasmodium infection

• Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more 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 mseconds), 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