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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158804
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
ThermoFisher Scientific Brahms Biomarkers France
Information provided by (Responsible Party):
Michael K. Mansour, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Pneumonia, Bacterial Diagnostic Test: procalcitonin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Procalcitonin algorithm+stewardship team
antibiotic prescription guided by PCT values
Diagnostic Test: procalcitonin
accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection

No Intervention: standard group
standard of care guided by current guidelines



Primary Outcome Measures :
  1. total days of antibiotic treatment [ Time Frame: 30 days ]
    difference in antibiotic exposure and adverse outcomes between standard of care group and PCT group


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: 30 days ]
    difference in length of hospital stay and resource utilization between standard of care and PCT group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized adult patients ≥ 18 years of age
  • Suspected or confirmed LRTI (i.e. community-acquired pneumonia, acute bronchitis or AECOPD) <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 hrs of hospitalization

Exclusion Criteria:

  • Less than 18 years of age
  • Patients who are not admitted to the hospital
  • Patients transferred to an outside hospital
  • Patients leaving against medical advice
  • Unable to determine antibiotic duration prescribed upon discharge
  • Known Pregnancy
  • Primary and acquired cell-mediated immune deficiency (chronic immunosuppressive therapy > 10 mg prednisone; HIV with CD4 <350 cells/mm³; active malignancy with receipt of systemic chemotherapy)
  • Neutropenia
  • Patients with cystic fibrosis
  • Infection where long course antibiotics are the standard of care (Acinetobacter associated with indwelling catheters, Listeria, Legionella, Mycobacterium tuberculosis, Pneumocystis jirovecii, or Toxoplasma gondii); cavitary pneumonia; bronchiectasis history of and on admission
  • Concomitant nonpulmonary bacterial infection that requires antibiotic therapy
  • Antibiotics given for non-infectious indications (e.g. rifaximin for hepatic encephalopathy)
  • Patients receiving antibiotic therapy for surgical prophylaxis, skin and skin structure infections, bone and joint infections, infections involving cardiac tissue, chronic infections requiring long-course antibiotic treatment (including but not limited to bronchiectasis, endocarditis, brain abscess, deep or complex abscess, following cardiac bypass surgery
  • Patients receiving dialysis for end-stage renal disease
  • Patients with solid organ transplant, bone marrow transplant or stem cell transplant recipient
  • Surgical patients or patients receiving antibiotics for surgical prophylaxis
  • ST elevation
  • Moribund patients
  • Patient experienceing major trauma and/or burns or patient under ECMO
  • Patient diagnosed with active medullary C-cell carcinoma, small cell lung carcinoma or bronchial carcinoid or with other active malignancy requiring systemic chemotherapry
  • Patient with acute or chronic viral hepatitis and/or decompensated severe liver cirrhosis (Child-Plug Class C)
  • Patient with prolonged or severe cardiogenic shock, prolonged severe organ perfusion anomalies or after resuscitation from cardiac arrest
  • Patient with biliary pancreatitis, chemical pneumonitis or heat stroke
  • Patient with invasive fungal infections (e.g. candidiasis, aspergillosis) or actue attacks of plasmodium falciparum marlaria
  • Patients under treatment with OKT3 antibodies, OK-432, interleuking, TNF-alpha and other dugs stimulating the release of pro-inflammatory cytokines or resulting in anaphylaxis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158804


Contacts
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Contact: Michael K Mansour, MD, PhD 617-726-6726 mkmansour@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
ThermoFisher Scientific Brahms Biomarkers France
Investigators
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Principal Investigator: Michael K Mansour, MD, PhD Massachusetts General Hospital
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Responsible Party: Michael K. Mansour, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04158804    
Other Study ID Numbers: 2019P000362
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections