KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic use (KIPRUN): protocol for a multicentre, randomised, superiority trial to compare the efficacy and safety of procalcitonin kinetics-guided and absolute procalcitonin value-guided antibiotic initiation in critically ill patients

Introduction Appropriate antibiotic (AB) therapy remains a challenge in intensive care units (ICUs). Guidelines recommend against using procalcitonin (PCT) to guide the initiation of AB therapy, although with low certainty and a very low level of evidence.

Recent studies suggest that changes in PCT levels may be more accurate than a single measurement; however, this has never been tested in a randomised trial. Methods and analysis In this multicentre, randomised controlled trial (RCT), we aim to compare the efficacy and safety of two different PCT protocols for initiating AB therapy.

Hemodynamically stable, critically ill adult patients with suspected new-onset infection at admission or during ICU stay will be randomised in a 1:1 ratio. In the treatment arm (Kinetics Group, KG), initiation of AB treatment is strongly recommended if PCT ≥0.5 ng/mL and increases by more than 100% compared with the previous day.

In the control arm (Absolute Group, AG), the initiation of AB treatment is strongly recommended if PCT ≥0.5 ng/mL.