NCT04158804

PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT

PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	procalcitonin	accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection

Timeline

• Start date: 2020-05-28
• Primary completion: 2023-06-17
• Completion: 2023-06-17
• First posted: 2019-11-12
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study