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. 2023 Jul 4;10(7):ofad329.
doi: 10.1093/ofid/ofad329. eCollection 2023 Jul.

Carbapenem-Resistant Acinetobacter spp Infection in Critically Ill Patients With Limited Treatment Options: A Descriptive Study of Cefiderocol Therapy During the COVID-19 Pandemic

Maddalena Giannella  1   2 , Stefano Verardi  3 , Andreas Karas  3 , Hasania Abdel Hadi  4 , Hervé Dupont  5 , Alex Soriano  6   7 , Anne Santerre Henriksen  3 , Andrew Cooper  8 , Marco Falcone  9 ; ARES Study Group
Collaborators, Affiliations

Carbapenem-Resistant Acinetobacter spp Infection in Critically Ill Patients With Limited Treatment Options: A Descriptive Study of Cefiderocol Therapy During the COVID-19 Pandemic

Maddalena Giannella et al. Open Forum Infect Dis. .

Abstract

Background: Carbapenem-resistant Acinetobacter baumannii infections are difficult to treat and are a significant public health threat due to intrinsic/acquired resistance and limited treatment options.

Methods: A retrospective, observational cohort study in patients receiving cefiderocol via Shionogi's early access program for Acinetobacter spp infections (1 April 2020-30 April 2021; 27 sites; Italy, Spain, Germany, France). Primary outcome was clinical success, defined as clinical resolution of infection at day 14 or day 28 survival.

Results: Overall, 147 patients were included. Primary infection sites were respiratory (65.3%) and bloodstream (unknown source [15.6%]; catheter-related [10.9%]); 24.5% of patients had polymicrobial infection. Of 136 patients in intensive care (92.5%), 85.3% (116/136) received mechanical ventilation. Septic shock (55.6% [70/126]) and coronavirus disease 2019 (COVID-19) (81.6%) were prevalent. Prior to cefiderocol, 85.0% of patients received gram-negative treatment, 61.2% received ≥2 antimicrobials, and most received colistin (58.5%; median duration, 11.5 days). Cefiderocol monotherapy was used in 30.6% of patients. Clinical success rate was 53.1% and was higher in patients without septic shock (62.5%), without COVID-19 (77.8%), and with lower Sequential Organ Failure Assessment (SOFA) scores (quartile 1 [median, 3; range, 0-5]: 82.9%). Day 28 survival was 44.9% and was higher in patients without septic shock (60.7%), without COVID-19 (59.3%), with lower SOFA score (quartile 1: 82.9%), and receiving first-line cefiderocol (68.2% [15/22]). Resolution of infection at day 14 occurred in 39.5% of patients.

Conclusions: Despite use in complex patients with limited treatment options and high septic shock/COVID-19 rates, cefiderocol treatment was associated with an overall clinical success rate of 53%.

Keywords: Acinetobacter; COVID-19; cefiderocol; mortality; septic shock.

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Conflict of interest statement

Potential conflicts of interest. M. G. has received honoraria for lectures, presentations, or speaker’s bureaus from MSD, Shionogi, Pfizer, and Gilead, and for participation on a data safety monitoring board or advisory board from MSD and Pfizer. S. V., A. K., and A. C. are employees of Shionogi B.V. H. D. has received fees from Shionogi for conferences and expert advisory boards. A. S. has received honoraria for lectures and advisory boards from Pfizer, MSD, Shionogi, Menarini, and Gilead. A. S. H. is an employee of Maxel Consulting ApS (Jyllinge, Denmark) and is a contractor for Shionogi B.V. M. F. has received grants and/or speaker honoraria from MSD, Angelini, Shionogi, Pfizer, Gilead, Menarini, and Nordic Pharma. H. A. H. reports no potential conflicts of interest.

Figures

Figure 1.
Figure 1.
Flowchart of patient record selection from screening of the early access program database. Abbreviations: CR, carbapenem-resistant; EAP, early access program.
Figure 2.
Figure 2.
Kaplan-Meier survival rates up to day 28 (n = 147). Survival probability curves were analyzed based on recorded dates of cefiderocol initiation and death. There may be discrepancies between these recorded dates and the deaths registered at day 28 in the case report form. A, Total population. B, By presence/absence of septic shock. C, By presence/absence of coronavirus disease 2019 (COVID-19). D, By Sequential Organ Failure Assessment (SOFA) score quartiles. Septic shock was defined as a score of 3 or 4 on the cardiovascular domain on the SOFA score at time of cefiderocol initiation. SOFA scores of 0 were imputed for individual SOFA domains where data were missing, providing a value was recorded for at least 1 of the 6 SOFA domains.
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References

    1. World Health Organization . Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis. 2017. Available at:https://apps.who.int/iris/handle/10665/311820. Accessed 6 June 2023.
    1. European Centre for Disease Prevention and Control . Rapid risk assessment: carbapenem-resistant Acinetobacter baumannii in healthcare settings. 2016. Available at:https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Pub.... Accessed 6 June 2023.
    1. Pascale R, Bussini L, Gaibani P, et al. . Carbapenem-resistant bacteria in an intensive care unit during the coronavirus disease 2019 (COVID-19) pandemic: a multicenter before-and-after cross-sectional study. Infect Control Hosp Epidemiol 2022; 43:461–6. - PMC - PubMed
    1. Gaibani P, Viciani E, Bartoletti M, et al. . The lower respiratory tract microbiome of critically ill patients with COVID-19. Sci Rep 2021; 11:10103. - PMC - PubMed
    1. O’Toole RF. The interface between COVID-19 and bacterial healthcare-associated infections. Clin Microbiol Infect 2021; 27:1772–6. - PMC - PubMed