Clinical trial NCT02130986: Procalcitonin Antibiotic Consensus Trial (ProACT)
Official title: Procalcitonin Antibiotic Consensus Trial (ProACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Respiratory Tract Infection (LRTI)
Keywords: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: BioMérieux
First posted: 2014-05-06
Enrollment: 1664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total Antibiotic Exposure Days
timeFrame: 30 days
measure: Number of Participants With Any Adverse Outcome
timeFrame: 30 days
Secondary outcomes:
measure: Antibiotic Prescription in Emergency Department(ED)
timeFrame: While in the ED or before ED discharge (majority patients < 1 day)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland/Baltimore
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Detroit Receiving Hospital
state: Michigan
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University, College of Medicine
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey College of Medicine; Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David T Huang, MD MPH
role: PRINCIPAL_INVESTIGATOR
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