Clinical outcome studies involve the testing of optimised dosing regimens derived from workstream 3 in a clinical setting to assess safety and tolerability in target patient populations.

Clinical outcome studies will be led by Workstream 4 Lead, Dr Hafiz Abdul Aziz, and he will be responsible for collating studies’ status, progress and milestone reports and ensuring they are escalated to the Operations Committee or Steering Committee for consideration and advice.

The objective of this workstream is to use the applied knowledge-to-action adaptive framework to implement antimicrobial dosing interventions into clinical practice and policy.

Workstream 4. Clinical trials
Project Lead
Measure implementation of dosing software to achieve clinical outcomes and understand feasibility, acceptability and end-user perceptions.
Support development of new antimicrobial dosing guidelines for treatment of difficult infections through publication via Australian and international societies as well as incorporation into relevant Australian policy
Multinational randomised controlled trial (RCT) of clinical outcomes of continuous infusion vs intermittent beta-lactam antimicrobial administration in critically ill patients with severe sepsis and not receiving RRT, the BLING III Study
Safety & tolerability ROAD 
Test the safety and tolerability of Resistance Optimised Antimicrobial Dosing (ROAD) Study in a general infected critically ill patient population using published drug exposures
Safety & tolerability of ELF 
Test the safety and tolerability of resistance optimised dosing in the ELF of critically ill patients with pneumonia (extension of Project 1)
Safety & tolerability nebulised combination 
Test the safety and tolerability of resistance optimised nebulised tobramycin + IV beta-lactam antimicrobial combination.