Cohort Event Monitoring Study of Pyramax®

• Status: Completed
• Trial end date: 2019-04-10
• Target enrollment: 0
• Participant gender: All

Summary

The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (<1 year of age).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Collaborator: Medicines for Malaria Venture
• Treatments: Artesunate; Pyronaridine

Criteria

Inclusion Criteria:

• Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:

• Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children.

• Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear). analysis).

• Weight ≥5 kg - < 20 kg (granules); ≥20 kg (tablets).

• Ability to take an oral medication.

• Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old) and on signed assent form for minors that could be required per national regulations in each participating country.

• The patient has to comply with all scheduled follow-up visits.

Exclusion Criteria:

• Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4).

• Known allergy to artemisinin and/or to pyronaridine.

• Known pregnancy.

• Lactating women should be excluded if other anti-malarial treatments are available.

• Complicated malaria as per WHO definition (Annex 2)

• Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.

• Patients having been treated with Pyramax in the previous 28 days.