MedicalResearch.com Interview with:
David T. Huang, MD, MPH
Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science
Director, MACRO (Multidisciplinary Acute Care Research Organization)
Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness)
University of Pittsburgh
MedicalResearch.com: What is the background for this study?
Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them.
Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral.
We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events.
The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription.
MedicalResearch.com: What are the main findings?
Response: In contrast to previous research, the ProACT trial showed that the procalcitonin guideline had little overall impact on whether or not the physicians prescribed antibiotics, although in patients with acute bronchitis, antibiotic prescription in the emergency department was cut in half in patients whose physicians were provided the procalcitonin guideline. The finding for acute bronchitis however, was a secondary analysis.
The exact reasons why the results of this recent research contrast with previous studies are unclear, but we found that procalcitonin test results generally matched up with how sick a patient looked as well as their physician’s judgment on how likely it was they had a bacterial infection. We also found that even when physicians did not know their patient’s procalcitonin result, their decision to prescribe antibiotics was generally the same as when physicians did know the result.
In other words, it seems likely that physicians already commonly withheld antibiotics based on clinical signs alone, and, therefore, instead of the magic bullet I and many others hoped procalcitonin might be, it offered only limited incremental value over clinical judgment.
MedicalResearch.com: What should readers take away from your report?
Response: Antibiotic overuse has received increased attention since the last large prior trial of procalcitonin and lower respiratory tract infection was completed 10 years ago. I hope the results of the ProACT trial will help clinicians decide when to order procalcitonin when evaluating a patient with suspected lower respiratory tract infection. More broadly, at least in hospitals similar to the 14 centers that participated in ProACT, it would appear that implementation of a procalcitonin antibiotic prescribing guideline will have limited impact.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Our findings indicate the need for future research and randomized trials to determine the clinical utility of other novel biomarkers and diagnostic tests in general.
David T. Huang, M.D., M.P.H., Donald M. Yealy, M.D., Michael R. Filbin, M.D., Aaron M. Brown, M.D., Chung-Chou H. Chang, Ph.D., Yohei Doi, M.D., Ph.D., Michael W. Donnino, M.D., Jonathan Fine, M.D., Michael J. Fine, M.D., Michelle A. Fischer, M.D., M.P.H., John M. Holst, D.O., Peter C. Hou, M.D., for the ProACT Investigators
July 19, 2018 N Engl J Med 2018; 379:236-249 DOI: 10.1056/NEJMoa1802670
David T. Huang, M.D., M.P.H., Donald M. Yealy, M.D., Michael R. Filbin, M.D., Aaron M. Brown, M.D., Chung-Chou H. Chang, Ph.D., Yohei Doi, M.D., Ph.D., Michael W. Donnino, M.D., Jonathan Fine, M.D., Michael J. Fine, M.D., Michelle A. Fischer, M.D., M.P.H., John M. Holst, D.O., Peter C. Hou, M.D., et al., for the ProACT Investigators*
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