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Procalcitonin Antibiotic Consensus Trial (ProACT) (ProACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02130986
First Posted: May 6, 2014
Last Update Posted: August 10, 2017
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. Read our disclaimer for details.
Collaborators:
National Institute of General Medical Sciences (NIGMS)
BioMérieux
Information provided by (Responsible Party):
David T. Huang, MD, MPH, University of Pittsburgh
  Purpose
The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in emergency department (ED) patients with lower respiratory tract infection (LRTI).

Condition Intervention
Lower Respiratory Tract Infection (LRTI) Other: Procalcitonin level Other: Results of procalcitonin (PCT) level to treating clinician Other: Provide procalcitonin guideline to treating clinician Other: Telephone Visit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Procalcitonin Antibiotic Consensus Trial (ProACT)

Resource links provided by NLM:


Further study details as provided by David T. Huang, MD, MPH, University of Pittsburgh:

Primary Outcome Measures:
  • Total antibiotic exposure days [ Time Frame: 30 days ]
    Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.

  • Combined endpoint of adverse outcomes that could be attributable to withholding antibiotics in LRTI [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Rate of antibiotic initiation by the initial ED clinician [ Time Frame: during initial ED visit ]

Enrollment: 1664
Actual Study Start Date: November 3, 2014
Study Completion Date: July 10, 2017
Primary Completion Date: July 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procalcitonin (PCT) group
Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
Other: Procalcitonin level
A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.
Other Name: PCT level
Other: Results of procalcitonin (PCT) level to treating clinician
In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.
Other: Provide procalcitonin guideline to treating clinician

Procalcitonin antibiotic guideline --

Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation

< 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1)

0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1)

> 0.25 - 0.5 -- Likely -- Antibiotics recommended(2)

> 0.5 -- Very likely -- Antibiotics strongly recommended(2)

  1. Initial antibiotics can be considered for critical illness, Legionella pneumophilia. Procalcitonin should be evaluated in context with all findings and the total clinical status; clinical judgment always necessary.
  2. For outpatients, antibiotic duration based on level (> 0.25-0.5 ug/L:3 days; > 0.5-1.0 ug/L:5 days; >1.0 ug/L:7 days). Physician follow-up is recommended.
Other: Telephone Visit
We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30
Active Comparator: Usual Care group
Telephone Visit at Day 15 and Day 30
Other: Telephone Visit
We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30

Detailed Description:

There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance.

Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy.

Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • A primary clinical diagnosis in the ED of acute LRTI (< 28 days duration)
  • Clinician willing to consider procalcitonin in antibiotic decision-making

Exclusion Criteria:

  • Systemic antibiotics before ED presentation (All prophylactic antibiotic regimens, OR received >1 dose within 72 hours prior to ED presentation)
  • Current vasopressor use
  • Mechanical ventilation (via endotracheal tube)
  • Known severe immunosuppression
  • Accompanying non-respiratory infections
  • Known lung abscess or empyema
  • Chronic dialysis
  • Metastatic cancer
  • Surgery in the past 7 days (excluding minor surgery such as skin biopsy)
  • Incarcerated or homeless
  • Enrolled in ProACT in the past 30 days
  Contacts and Locations
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): NCT02130986


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
University of California at Irvine Medical Center
Orange, California, United States, 92868
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Maryland
University of Maryland/Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
United States, Minnesota
Essentia Institute of Rural Health
Duluth, Minnesota, United States, 55805
United States, Ohio
The Ohio State University, College of Medicine
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Penn State Hershey College of Medicine; Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
National Institute of General Medical Sciences (NIGMS)
BioMérieux
Investigators
Principal Investigator: David T Huang, MD MPH University of Pittsburgh
  More Information

Publications:

Responsible Party: David T. Huang, MD, MPH, Associate Professor of Critcal Care and Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02130986     History of Changes
Other Study ID Numbers: 1R01GM101197 ( U.S. NIH Grant/Contract )
First Submitted: May 1, 2014
First Posted: May 6, 2014
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by David T. Huang, MD, MPH, University of Pittsburgh:
procalcitonin (PCT)
lower respiratory tract infection (LRTI)
antibiotic exposure
antibiotic decision making
community acquired pneumonia (CAP)
chronic obstructive pulmonary disease (COPD) exacerbation
acute asthma exacerbation
acute bronchitis
procalcitonin guideline

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs