A Comparative Pharmacokinetic Study of Antibiotics for the Treatment of Non-Tuberculous Mycobacteria in Patients with Cystic Fibrosis

niversity of Queensland0 个研究点目标入组 20 人开始时间: 2019年7月5日最近更新: 2023年2月6日

研究概览

暂无简介。

•Age greater or equal to 18 years and able to give consent or under 18 with the consent of a substitute decision maker.
•A negative screen for mycobacteria within the last 6 months for those who are being given a single dose of antibiotics.
•Availability of suitable intravenous access to facilitate sample collection
•Written informed consent has been obtained from the patient or substitute decision maker (according to local regulatory statements for ethical conduct of research at each study site)
•able to tolerate full diet without nasogastric or PEG feeding

•Known adverse reaction to anti-mycobacterial drug being used in study
•On a non-study drug which may have clinically significant interactions with study drug
•Unavailability of intravenous access device for blood collection
•Treating clinicians concerns that the total of volume of blood to be collected may be worsen pre-existing anaemia defined as haemoglobin < 70 g/L.
•Abnormal liver function, at screening, defined as greater than or equal to (>=) 3 time upper limit of normal (ULN), of any 3 or more of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase (ALP), total bilirubin
•Renal impairment with eGFR less than 30 mls/min
•Prolonged QTc of >500ms on ECG or history of cardiac arrhythmia

发起方

niversity of Queensland