Procalcitonin Antibiotic Consensus Trial (ProACT)



Status:Completed
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:November 3, 2014
End Date:July 21, 2017

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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).

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.

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
We found this trial at
13
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Michael Donnino, MD
Phone: 617-754-2341
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Principal Investigator: Feras Khan, MD
Phone: 410-328-8025
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Michael Kurz, MD
Phone: 205-934-4011
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael Filbin, MD
Phone: 617-724-0348
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Peter C. Hou, MD
Phone: 617-732-5640
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Columbus, Ohio 43210
Principal Investigator: Thomas Terndrup, MD
Phone: 614-293-6185
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Detroit, MI
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Duluth, Minnesota 55805
Principal Investigator: John M Holst, DO
Phone: 218-786-1220
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Duluth, MN
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Hershey, Pennsylvania 17033
Principal Investigator: Michelle Fischer, MD
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Norwalk, Connecticut 06856
Principal Investigator: Jonathan Fine, MD
Phone: 203-855-3543
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Norwalk, CT
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101 The City Drive South
Orange, California 92868
714-456-7890
Principal Investigator: Shahram Lotfipour, MD, MPH
Phone: 714-456-3489
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Phoenix, Arizona 85008
Principal Investigator: Frank LoVecchio, DO, MPH
Phone: 602-239-2358
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Aaron Brown, MD
Phone: 412-647-5023
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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