N/A
Completed N=700
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
Pneumonia, Bacterial
Source: ClinicalTrials.gov NCT04158804 ↗
Enrolled (actual)
700
Serious AEs
22.4%
Results posted
Mar 2025
Primary outcomePrimary: Short Treatment of Pneumonia — 47; 87 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Treatment of Pneumonia |
47; 87 | — |
| SECONDARY Composite Safety Adverse Event Rate |
72; 90 | — |
| SECONDARY Antibiotic Exposure at Discharge |
0; 0 | — |
| SECONDARY Days of Therapy Per 1000 Patient Days |
1.25; 1.14 | — |
| SECONDARY Length of Stay |
4; 4 | — |
| SECONDARY ICU Admissions |
43; 49 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized adult patients ≥ 18 years of age
- Suspected or confirmed pneumonia 2 weeks) other than anti-inflammatory reasons.
- Neutropenia ( 15, and/or burns or patient under extracorporeal circulation confirmed by a second research staff member.
- Patient with acute viral hepatitis and/or decompensated severe liver cirrhosis (Child-Pugh Class C).
- Patient with prolonged or severe cardiogenic shock, defined as decreased cardiac output leading to end organ injury (e.g. severe hypotension or AKI or oliguria or altered mental status or cool extremities or respiratory distress AND evidence of metabolic acidosis on lab testing)
- Patient with pancreatitis, chemical pneumonitis or heat stroke
- Active infection with invasive fungal pathogen (e.g. candidiasis, aspergillosis) or plasmodium falciparum malaria or mycobacteria
- Patient under treatment with OKT3 antibodies, OK-432, interleukins, TNF-alpha and other drugs stimulating the release of pro-inflammatory cytokines or resulting in anaphylaxis.
- Patient is under hospice care
- Patient with ventilator associated pneumonia
- Patients with untreated, active, and symptomatic autoimmune disease
- Patients with empyema, abscess, or cavitary/necrotizing pneumonia
- Patients actively enrolled in other clinical trial involving immunomodulatory therapy
Data sourced from ClinicalTrials.gov (NCT04158804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.