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

NCT04158804 | Completed Results DMC FDA Device

• 1 other identifier: 2019P000362
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Short Treatment of Pneumonia

  Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx")

  30 days

Secondary Outcomes (5)

• Composite Safety Adverse Event Rate

  30 days

• Antibiotic Exposure at Discharge

  30 days

• Days of Therapy Per 1000 Patient Days

  30 days

• Length of Stay

  30 days

• ICU Admissions

  30 days

Other Outcomes (2)

• Clostridium Difficile Infection (CDI)

  30 days

• Healthcare Economic Endpoints

  30 days

Study Arms (2)

Procalcitonin algorithm+stewardship team

EXPERIMENTAL

antibiotic prescription guided by PCT values

Diagnostic Test: procalcitonin

standard group

NO INTERVENTION

standard of care guided by current guidelines

Interventions

procalcitonin DIAGNOSTIC_TEST

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

Procalcitonin algorithm+stewardship team

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• BRAHMS GmbH: collaborator
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (6)

Charlotte Hungerford Hospital

Torrington, Connecticut, 06790, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Martha's Vineyard Hospital

Oak Bluffs, Massachusetts, 02557, United States

Location

North Shore Medical Center

Salem, Massachusetts, 01970, United States

Location

Texas Health Harris Methodist Hospital

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Michael K. Mansour, MD, Ph.D.
• Organization: Massachusetts General Hospital

mkmansour@mgb.org

617-726-6726

Study Officials

• Michael K Mansour, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: May 28, 2020
• Primary Completion: June 17, 2023
• Study Completion: June 17, 2023
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)