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Table 3 Outcomes

From: Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection

CONSORT ProACT
Outcomes
 Primary Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30 a
A combined endpoint of adverse outcomes that could be attributable to withholding antibiotics in LRTI, that occur by study Day 30 b:
 i. death
 ii. septic shock (vasopressor use for >1 h)
 iii. Mechanical ventilation (via endotracheal tube)
 iv. renal failure (KDIGO, stage 3) [50]
 v. lung abscess/empyema
 vi. development of pneumonia in non-pneumonia LRTI
 vii. Subsequent hospitalization
 Secondary Antibiotic initiation by the initial ED clinician
Hospital length of stay
90d and 1 year mortality
Intensive care unit admission
Subsequent ED visits
Quality of life (Airway Questionnaire 20) [57]
 Data quality methods Standardized data collection and recording
Web-based DCF with built-in logic checks, automatic data queries, and streamlined user interface
Periodic DCF checks to monitor data irregularities and protocol compliance
Study coordinator DCF training and periodic conference calls
Center monitoring visits and review of source documents
  1. LRTI lower respiratory tract infection, KDIGO Kidney Disease Improving Global Outcomes, ED emergency department, DCF data collection form
  2. aWe define an antibiotic-day as each day a participant receives any oral or intravenous antibiotics, excluding antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy) and antivirals
  3. bprimary safety outcome