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Procalcitonin Antibiotic Consensus Trial (ProACT) (ProACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Pittsburgh
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
BioMérieux
Information provided by (Responsible Party):
David T. Huang, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02130986
First received: May 1, 2014
Last updated: November 21, 2016
Last verified: November 2016
  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 Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Procalcitonin Antibiotic Consensus Trial (ProACT)

Resource links provided by NLM:


Further study details as provided by 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 ]

Estimated Enrollment: 1514
Study Start Date: November 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130986

Contacts
Contact: Elizabeth A Gimbel, BS 412-647-7776 gimbele@upmc.edu
Contact: Kourtney A Wofford, BA 412-647-2584 woffordka@upmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Nive Patkar    205-934-4011    npatkar@uabmc.edu   
Principal Investigator: Michael Kurz, MD         
Sub-Investigator: David McCollum, MD         
United States, Arizona
Maricopa Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Frank LoVecchio, DO, MPH    602-239-2358    Frank.LoVecchio@bannerhealth.com   
Contact: Mary Mulrow, RN, MN    602-344-5058    Mary_mulrow@medprodoctors.com   
Principal Investigator: Frank LoVecchio, DO, MPH         
Sub-Investigator: Thomas Ardilles, MD         
United States, California
University of California at Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Rick Jones    714-456-3489    jonesrd@uci.edu   
Principal Investigator: Shahram Lotfipour, MD, MPH         
Sub-Investigator: Matthew J Butteri, MD         
United States, Connecticut
Norwalk Hospital Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Jonathan Fine, MD    203-855-3543    jonathan.fine@norwalkhealth.org   
Contact: Christine Belden, RN    203-852-3021    christine.belden@norwalkhealth.org   
Principal Investigator: Jonathan Fine, MD         
Sub-Investigator: Jean Hammel, MD         
United States, Maryland
University of Maryland/Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gentry Wilkerson, MD    410-328-8025    gwilkerson@em.umaryland.edu   
Contact: Dana Beach       dbeach@em.umaryland.edu   
Principal Investigator: Gentry Wilkerson, MD         
Sub-Investigator: Michael Winters, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Filbin, MD    617-724-0348    mfilbin@partners.org   
Contact: Blair Parry, BA    617-724-4758    bparry@partners.org   
Principal Investigator: Michael Filbin, MD         
Sub-Investigator: Michael Mansour, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Peter C. Hou, MD    617-732-5640    phou@partners.org   
Contact: Wanlu Xu       WXU9@PARTNERS.ORG   
Principal Investigator: Peter C. Hou, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Donnino, MD    617-754-2341    mdonnino@bidmc.harvard.edu   
Contact: Varun Konanki       vkonanki@bidmc.harvard.edu   
Principal Investigator: Michael Donnino, MD         
United States, Michigan
Wayne State University/Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Joshua Phillip    313-966-0585    jphillip@med.wayne.edu   
Principal Investigator: Robert Sherwin, MD         
United States, Minnesota
Essentia Institute of Rural Health Recruiting
Duluth, Minnesota, United States, 55805
Contact: Kristina Ankrum, RN BS    218-786-1220    Kristina.Ankrum@essentiaHealth.org   
Principal Investigator: John M Holst, DO         
United States, Ohio
The Ohio State University, College of Medicine Recruiting
Columbus, Ohio, United States, 43210
Contact: Lauren Southerland, MD       Lauren.Southerland@osumc.edu   
Contact: Michael Hill    614-293-6185    michael.hill@osumc.edu   
Principal Investigator: Thomas Terndrup, MD         
Sub-Investigator: Laura Southerland, MD         
Sub-Investigator: Matthew Exline, MD         
United States, Pennsylvania
Penn State Hershey College of Medicine; Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert Rodgers, MD       drodgers@hmc.psu.edu   
Contact: Nancy Campbell    717-531-1707 ext 3    nflint@hmc.psu.edu   
Principal Investigator: Robert Rodgers, MD         
Sub-Investigator: Colleen Rafferty, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Denise Scholl    412-647-5023    scholldw@upmc.edu   
Principal Investigator: Aaron Brown, MD         
Sub-Investigator: Michael J. Fine, MD         
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 ( US NIH Grant/Contract Award Number )
Study First Received: May 1, 2014
Last Updated: November 21, 2016

Keywords provided by 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

ClinicalTrials.gov processed this record on March 24, 2017