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 个研究点目标入组 153 人开始时间: 2018年7月27日最近更新: 2020年1月6日

试验速览

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•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
•History of splenectomy
•Known history or evidence of clinically significant liver disorders, such as:
•-Known active Hepatitis A, e.g. by detection of anti HAV-IgM.
•-Known hepatitis B surface antigen (HBsAg) carrier.
•-Known hepatitis C antibody (HCV Ab).
•-Liver function test (AST and ALT levels) more than 2.5 times the upper limit of normal range.
•Total Bilirubin > 2 ULN

发起方

Ministry of Health, Viet Nam