Procalcitonin Antibiotic Consensus Trial (ProACT) (ProACT)

January 14, 2019 updated by: David T. Huang, MD, MPH, University of Pittsburgh
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1664

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Medical Center
    • California
      • Orange, California, United States, 92868
        • University of California at Irvine Medical Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland/Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Detroit Receiving Hospital
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Institute of Rural Health
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University, College of Medicine
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey College of Medicine; Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Antibiotic Exposure Days
Time Frame: 30 days
Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.
30 days
Number of Participants With Any Adverse Outcome
Time Frame: 30 days

Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI).

Number is based on the number of participants that experienced any adverse outcome.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic Prescription in Emergency Department(ED)
Time Frame: While in the ED or before ED discharge (majority patients < 1 day)
Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED.
While in the ED or before ED discharge (majority patients < 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of General Medical Sciences (NIGMS)
BioMérieux

Investigators

  • Principal Investigator: David T Huang, MD MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2014

Primary Completion (ACTUAL)

July 21, 2017

Study Completion (ACTUAL)

July 21, 2017

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (ESTIMATE)

May 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01GM101197 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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