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. 2022 May 9;9(7):ofac231.
doi: 10.1093/ofid/ofac231. eCollection 2022 Jul.

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

Stephen P Bergin  1 , Sara B Calvert  2 , John Farley  3 , Jie-Lena Sun  4 , Karen Chiswell  4 , Willem Dieperink  5 , Jan Kluytmans  6 , Juan Carlos Lopez-Delgado  7 , Rafael Leon-Lopez  8 , Marcus J Zervos  9 , Marin H Kollef  10 , Matthew Sims  11 , Badih A Kabchi  12 , Daniel Rubin  3 , Jonas Santiago  3 , Mukil Natarajan  3 , Pamela Tenaerts  2 , Vance G Fowler  1 , Thomas L Holland  1 , Marc J Bonten  13 , Sebastiaan J Hullegie  13
Affiliations

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

Stephen P Bergin et al. Open Forum Infect Dis. .

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.

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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.
See this image and copyright information in PMC

References

    1. Rosenthal VD, Bat-Erdene I, Gupta D, et al. . International Nosocomial Infection Control Consortium (INICC) report, data summary of 45 countries for 2012–2017: device-associated module. Am J Infect Control 2020; 48:423–32. - PubMed
    1. Weiner-Lastinger LM, Abner S, Edwards JR, et al. . Antimicrobial-resistant pathogens associated with adult healthcare-associated infections: summary of data reported to the National Healthcare Safety Network, 2015–2017. Infect Control Hosp Epidemiol 2020; 41:1–18. - PMC - PubMed
    1. Cox E, Nambiar S, Baden L. Needed: antimicrobial development. N Engl J Med 2019; 380:783–5. - PubMed
    1. Ambrose PG, Bhavnani SM, Ellis-Grosse EJ, Drusano GL. Pharmacokinetic-pharmacodynamic considerations in the design of hospital-acquired or ventilator-associated bacterial pneumonia studies: look before you leap! Clin Infect Dis 2010; 51(Suppl 1):S103–10. - PubMed
    1. Silverman JA, Mortin LI, Vanpraagh AD, et al. . Inhibition of daptomycin by pulmonary surfactant: in vitro modeling and clinical impact. J Infect Dis 2005; 191:2149–52. - PubMed