An open label study to assess the efficacy, safety and tolerability of pyronaridine-artesunate in the treatment of malaria infection caused by single or mixed species of Plasmodium falciparum, P. vivax, or P. malariae in Vietnam

Phase 4

Completed

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12618001429246
• Lead Sponsor: S Naval Medical Research Center-Asia and US Naval Medical Research Unit - Two

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-27
• Study Completion: 2019-11-18
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

•Adults and children with a body weight greater than or equal to 20 kg
•Symptomatic of malaria infection (i.e. history of fever within 24 hours and/or presence of fever greater than 37.5°C for axillary temperature or greater than 38.0°C for tympanic temperature.
•Microscopic confirmation of asexual (i.e. blood) stages of mono-infections of P. falciparum, P. vivax and P. malariae or mixed infections of the Plasmodium species.
•Parasitemia between 250/µL and less than 100 000/µL of blood.
•Glucose-6-Phosphate Dehydrogenase (G6PD) normal participants with mono-infection of P. vivax or mixed infections of P. vivax will be treated with primaquine to kill liver hypnozoites.
•Ability to take oral medication. Written informed consent given to participate in the trial by the patient or in case of children up to 17 years old (assent for children aged 10 to 17 years old) with adult or guardian permission.

Exclusion Criteria

•Pregnancy or lactation (urine test for ß HCG to be performed on any woman of child bearing age 10 to 55 years old).
•Hematocrit less than 20%.
•Parasitemia less than 250/µL or greater than 100 000/µL of blood.
•Signs or symptoms indicative of severe/cerebral malaria (WHO, 2014).
•Liver function test (AST/ALT levels) more than 2.5 times the upper limit of normal (ULN) range.
•Total bilirubin greater than 2 ULN.
•Use of an antimalarial drug in the preceding 4 weeks.
•History of splenectomy, heavy alcohol use or injecting drugs of abuse.
•Any other condition, which in the judgment of the study physician would make participation in the study unsafe for the potential study participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified