Measuring the antibiotic levels in people with cystic fibrosis taking treatment for mycobacterial lung infection.
- Conditions
- cystic fibrosisnon-tuberculous mycobacteriaInfection - Other infectious diseasesRespiratory - Other respiratory disorders / diseasesInflammatory and Immune System - Other inflammatory or immune system disordersHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12619000948190
- Lead Sponsor
- niversity of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the measured plasma concentration of rifampicin at different timepoints after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[rifampicin plasma Measurements at 1 hour (primary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.];The primary outcome is the measured plasma concentration of ethambutol at different time points after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[ethambutol plasma Measurements at 1 hour (primary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.];The primary outcome is the measured plasma concentration of clarithromycin at different time points after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[clarithromycin plasma Measurements at 1 hour (primary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.]
- Secondary Outcome Measures
Name Time Method a secondary outcome is the measured plasma concentration of azithromycin at different time points after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[azithromycin plasma measurements at 1 hour (secondary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.];a secondary outcome is the measured plasma concentration of clofazimine at different time points after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[clofazimine plasma measurements at 1 hour (secondary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.];a secondary outcome is the measured plasma concentration of minocycline at different time points after oral administration. PK parameters to be measured include C max, T max, half life, AUC.[minocycline plasma measurements at 1 hour (secondary outcome), 2 hours, 3 hours, 4 hours, 6 hours and 8 hours post dose.]