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

  • STATUS
    Recruiting
  • End date
    Oct 11, 2022
  • participants needed
    700
  • sponsor
    Massachusetts General Hospital
Updated on 11 March 2022
antibiotic therapy
antibiotics
procalcitonin
community acquired pneumonia

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).

Details
Condition Pneumonia, Bacterial
Treatment Procalcitonin
Clinical Study IdentifierNCT04158804
SponsorMassachusetts General Hospital
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Hospitalized adult patients ≥ 18 years of age
Suspected or confirmed pneumonia <28 days at time of admission to the hospital (ED) who are prescribed antibiotics
Minimum of 2 (two) blood samples available for PCT value assessment within 24 hours of hospitalization

Exclusion Criteria

Non-hospitalized patients
Patient has tested positive for SARS-CoV-2
Major surgeries, defined as any procedure in which an incision is made with the exception of superficial procedures (eyes, cornea, skin, dental procedures), organs removed, or normal anatomy altered (e.g. open thoracic, abdominal and/or major orthopedic surgery), in the past 1 month or expected surgical procedure or patient receiving antibiotics for surgical prophylaxis
Active malignancy and/or active chemotherapy within 3 months
Known pregnancy
Primary and acquired cell-mediated immune deficiency (HIV with CD4 <350 cells/mm³; receipt of systemic chemotherapy and/or biologics in the past 3 months for reasons other than malignancy)
Infection where long course antibiotics are the standard of care(>2 weeks) other than anti-inflammatory reasons
Neutropenia
Concomitant non-pulmonary bacterial infection that requires antibiotic therapy based on an active medical team decision
Patients with cystic fibrosis
Antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy)
Patients receiving dialysis for end-stage renal disease
Patients with solid organ transplant, bone marrow transplant or stem cell transplant recipient
Patient experiencing major trauma defined as any injury that could cause prolonged disability and/or an Injury Severity Score >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)
ST elevation myocardial infarction
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
Prior enrollment into this study within 30 days
Active infection with invasive fungal pathogen (e.g. candidiasis, aspergillosis) or plasmodium falciparum malaria or mycobacteria
Patients with untreated, active, and symptomatic autoimmune disease
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
Patients with empyema, abscess, or cavitary/necrotizing pneumonia
Patient is under hospice care
Patients actively enrolled in other clinical trial involving immunomodulatory therapy
Patient with ventilator associated pneumonia
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