PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts

Stephen P Bergin, Sara B Calvert, John Farley, Jie-Lena Sun, Karen Chiswell, Willem Dieperink, Jan Kluytmans, Juan Carlos Lopez-Delgado, Rafael Leon-Lopez, Marcus J Zervos, Marin H Kollef, Matthew Sims, Badih A Kabchi, Daniel Rubin, Jonas Santiago, Mukil Natarajan, Pamela Tenaerts, Vance G Fowler, Thomas L Holland, Marc J Bonten, Sebastiaan J Hullegie, Stephen P Bergin, Sara B Calvert, John Farley, Jie-Lena Sun, Karen Chiswell, Willem Dieperink, Jan Kluytmans, Juan Carlos Lopez-Delgado, Rafael Leon-Lopez, Marcus J Zervos, Marin H Kollef, Matthew Sims, Badih A Kabchi, Daniel Rubin, Jonas Santiago, Mukil Natarajan, Pamela Tenaerts, Vance G Fowler, Thomas L Holland, Marc J Bonten, Sebastiaan J Hullegie

Abstract

Background: The prospective identification of patients at high risk for hospital-acquired/ventilator-associated bacterial pneumonia may improve clinical trial feasibility and foster antibacterial development. In a prior study conducted in the United States, clinical criteria were used to prospectively identify these patients; however, these criteria have not been applied in a European population.

Methods: Adults considered high risk for pneumonia (treatment with ventilation or high levels of supplemental oxygen) in the intensive care units of 7 European hospitals were prospectively enrolled from June 12 to December 27, 2017. We estimated the proportion of high-risk patients developing pneumonia according to US Food and Drug Administration guidance and a subset potentially eligible for antibacterial trial enrollment. We compared patient characteristics, treatment exposures, and pneumonia incidence in a European cohort and a previously described US cohort.

Results: Of 888 high-risk patients, 211/888 (24%) were treated for possible pneumonia, and 150/888 (17%) met the Food and Drug Administration definition for hospital-acquired/ventilator-associated bacterial pneumonia. A higher proportion of European patients treated for possible pneumonia met the pneumonia definition (150/211 [71%] vs 537/1464 [37%]; P < .001). Among patients developing pneumonia, a higher proportion of European patients met antibacterial trial eligibility criteria (124/150 [83%] vs 371/537 [69%]; P < .001).

Conclusions: Clinical criteria prospectively identified high-risk patients with high rates of pneumonia in the European cohort. Despite higher rates of established risk factors and incident pneumonia, European patients were significantly less likely to receive antibiotics for possible pneumonia than US patients. Different treatment practices may contribute to lower rates of antibacterial trial enrollment in the United States.

Keywords: antibacterial agent; bacterial pneumonia; health care–associated pneumonia; intensive care unit; mechanical ventilator.

© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Screening, eligibility, and enrollment of ICU patients at risk for nosocomial pneumonia. Abbreviations: HABP/VABP, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia; ICU, intensive care unit.
Figure 2.
Figure 2.
Cumulative incidence of HABP/VABP in Europe and the United States. Abbreviation: HABP/VABP, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
Figure 3.
Figure 3.
Summary of study outcome (A) and patients lacking diagnostic criteria (B) for high-risk patients treated for possible HABP/VABP. Abbreviation: HABP/VABP, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
Figure 4.
Figure 4.
Comparison of HABP/VABP patients eligible for trial enrollment. Abbreviation: HABP/VABP, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

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