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

NCT ID: NCT04158804

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2023-06-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Procalcitonin algorithm+stewardship team

antibiotic prescription guided by PCT values

Group Type: EXPERIMENTAL

procalcitonin

Intervention Type: DIAGNOSTIC_TEST

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

standard group

standard of care guided by current guidelines

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

procalcitonin

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Patient has tested positive for SARS-CoV-2
• Non-hospitalized patients
• Patients admitted to home health
• 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 metastatic cancer or neuroendocrine tumor or liquid tumor and/or on check point inhibitors within 3 months or has signs of mucositis (e.g. mouth lesions or intestinal bleeding)
• 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 (<1,500 ANC)
• Concomitant non-pulmonary bacterial infection that requires antibiotic therapy based on an active medical team decision
• Antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy)
• Patients with cystic fibrosis
• Patients receiving dialysis
• Patients with solid organ transplant, bone marrow transplant or stem cell transplant recipient
• ST elevation myocardial infarction
• Prior enrollment into this study within 30 days
• 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).
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BRAHMS GmbH

UNKNOWN

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael K. Mansour

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael K Mansour, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Charlotte Hungerford Hospital

Torrington, Connecticut, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Martha's Vineyard Hospital

Oak Bluffs, Massachusetts, United States

North Shore Medical Center

Salem, Massachusetts, United States

Texas Health Harris Methodist Hospital

Fort Worth, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019P000362

Identifier Type: -

Identifier Source: org_study_id