Evaluation of the therapeutic efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated falciparum malaria in areas of artemisinin-resistant falciparum malaria in Viet Nam

Ministry of Health, Viet Nam0 sites153 target enrollmentJuly 27, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 27, 2018

End Date

January 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Ministry of Health, Viet Nam

•Adults less than or equal to 70 and children greater than or equal to 7 year old and greater than or equal to 20 kbw
•Symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever \>37\.5°c.
•Microscopic confirmation of asexual stages of P.falciparum, parasite density greater than or equal to' 1000 and below 150 000/asexual per micro liter
•Microscopic confirmation of asexual stages of P.falciparum (mono P. falciparum infection )
•Capability of taking an oral medication
•Written informed consent given to participate in the trial
•Willingness and ability to adhere to follow\-up visit schedule

•Children \< 7 year old and \< 20 kbw and Adults \> 70 year old.
•Pregnancy or lactation (urine test for ß HCG to be performed on any woman of child bearing age that is 18 to 45 years).
•Unmarried female aged 12\-18 years
•Signs or symptoms indicative of severe malaria:
•Impaired consciousness (Blantyre Coma Score \<5\)
•Severe anaemia (Hct\<20 % or Hb \< 8g/dl)
•Bleeding disorder –evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
•Respiratory, Kidney distress
•Severe jaundice
•Known hypersensitivity to artemisinins \- defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis to pyronaridine