Procalcitonin Antibiotic Consensus Trial (ProACT)

Not Applicable

Completed

Interventions: Other: Procalcitonin level
Other: Results of procalcitonin (PCT) level to treating clinician
Other: Provide procalcitonin guideline to treating clinician
Other: Telephone Visit

Brief Summary: 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).

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Procalcitonin (PCT) group	Telephone Visit	Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
Procalcitonin (PCT) group	Provide procalcitonin guideline to treating clinician	Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
Usual Care group	Telephone Visit	Telephone Visit at Day 15 and Day 30
Procalcitonin (PCT) group	Procalcitonin level	Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30
Procalcitonin (PCT) group	Results of procalcitonin (PCT) level to treating clinician	Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antibiotic Prescription in Emergency Department(ED)	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.

Locations (13): Brigham and Women's Hospital
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Boston, Massachusetts, United States
University of Alabama at Birmingham
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Birmingham, Alabama, United States
University of California at Irvine Medical Center
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Orange, California, United States
University of Maryland/Baltimore
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Baltimore, Maryland, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Essentia Institute of Rural Health
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Duluth, Minnesota, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
Wayne State University/Detroit Receiving Hospital
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Detroit, Michigan, United States
The Ohio State University, College of Medicine
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Columbus, Ohio, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Penn State Hershey College of Medicine; Milton S. Hershey Medical Center
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Hershey, Pennsylvania, United States
Norwalk Hospital
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Norwalk, Connecticut, United States
Maricopa Medical Center
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Phoenix, Arizona, United States