Sample Size

Cross-source consensus on Sample Size from 1 sources and 6 claims.

1 sources · 6 claims

Benefits

Evidence quality

Other

Highlighted claims

The planned sample size is 250 patients. — 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
The primary outcome will be analyzed with Fisher's exact test. — 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
Analyses will use both per-protocol and intention-to-treat populations. — 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
An interim analysis is planned after 125 enrolled patients, with sample-size re-estimation allowed to preserve power. — 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
Expert consensus defined a clinically relevant reduction as cutting unnecessary treatment from about 30% to 15%. — 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
The trial assumes that up to 30% of critically ill patients are incorrectly considered infected and receive unjustified antibiotics. — 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