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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,664
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.
In the ED, we will quickly (\<1 hour goal) provide clinicians the procalcitonin result.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Maricopa Medical Center
Phoenix, Arizona, United States
University of California at Irvine Medical Center
Total Antibiotic Exposure Days
Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.
Time frame: 30 days
Number of Participants With Any Adverse Outcome
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.
Time frame: 30 days
Antibiotic Prescription in Emergency Department(ED)
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.
Time frame: While in the ED or before ED discharge (majority patients < 1 day)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30
Orange, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
University of Maryland/Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, United States
Essentia Institute of Rural Health
Duluth, Minnesota, United States
...and 3 more locations