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Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU) : a randomised, open-label, proof-of-concept trial

Lore Vanderbeke, Nico A. F. Janssen, Dennis C. J. J. Bergmans, Marc Bourgeois, Jochem B. Buil, Yves Debaveye, Pieter Depuydt (UGent) , Simon Feys, Greet Hermans, Oscar Hoiting, et al.
(2021) INTENSIVE CARE MEDICINE. 47(6). p.674-686
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Abstract
Purpose Influenza-associated pulmonary aspergillosis (IAPA) is a frequent complication in critically ill influenza patients, associated with significant mortality. We investigated whether antifungal prophylaxis reduces the incidence of IAPA. Methods We compared 7 days of intravenous posaconazole (POS) prophylaxis with no prophylaxis (standard-of-care only, SOC) in a randomised, open-label, proof-of-concept trial in patients admitted to an intensive care unit (ICU) with respiratory failure due to influenza (ClinicalTrials.gov, NCT03378479). Adult patients with PCR-confirmed influenza were block randomised (1:1) within 10 days of symptoms onset and 48 h of ICU admission. The primary endpoint was the incidence of IAPA during ICU stay in patients who did not have IAPA within 48 h of ICU admission (modified intention-to-treat (MITT) population). Results Eighty-eight critically ill influenza patients were randomly allocated to POS or SOC. IAPA occurred in 21 cases (24%), the majority of which (71%, 15/21) were diagnosed within 48 h of ICU admission, excluding them from the MITT population. The incidence of IAPA was not significantly reduced in the POS arm (5.4%, 2/37) compared with SOC (11.1%, 4/36; between-group difference 5.7%; 95% CI - 10.8 to 21.7; p = 0.32). ICU mortality of early IAPA was high (53%), despite rapid antifungal treatment. Conclusion The higher than expected incidence of early IAPA precludes any definite conclusion on POS prophylaxis. High mortality of early IAPA, despite timely antifungal therapy, indicates that alternative management strategies are required. After 48 h, still 11% of patients developed IAPA. As these could benefit from prophylaxis, differentiated strategies are likely needed to manage IAPA in the ICU.
Keywords
Critical Care and Intensive Care Medicine, Aspergillosis, Influenza, Posaconazole, Critical illness, Prophylaxis, AZOLE RESISTANCE, PROPHYLAXIS, SURVEILLANCE, FLUCONAZOLE, FUMIGATUS, VIRUS

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MLA
Vanderbeke, Lore, et al. “Posaconazole for Prevention of Invasive Pulmonary Aspergillosis in Critically Ill Influenza Patients (POSA-FLU) : A Randomised, Open-Label, Proof-of-Concept Trial.” INTENSIVE CARE MEDICINE, vol. 47, no. 6, 2021, pp. 674–86, doi:10.1007/s00134-021-06431-0.
APA
Vanderbeke, L., Janssen, N. A. F., Bergmans, D. C. J. J., Bourgeois, M., Buil, J. B., Debaveye, Y., … Wolfs, T. (2021). Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU) : a randomised, open-label, proof-of-concept trial. INTENSIVE CARE MEDICINE, 47(6), 674–686. https://doi.org/10.1007/s00134-021-06431-0
Chicago author-date
Vanderbeke, Lore, Nico A. F. Janssen, Dennis C. J. J. Bergmans, Marc Bourgeois, Jochem B. Buil, Yves Debaveye, Pieter Depuydt, et al. 2021. “Posaconazole for Prevention of Invasive Pulmonary Aspergillosis in Critically Ill Influenza Patients (POSA-FLU) : A Randomised, Open-Label, Proof-of-Concept Trial.” INTENSIVE CARE MEDICINE 47 (6): 674–86. https://doi.org/10.1007/s00134-021-06431-0.
Chicago author-date (all authors)
Vanderbeke, Lore, Nico A. F. Janssen, Dennis C. J. J. Bergmans, Marc Bourgeois, Jochem B. Buil, Yves Debaveye, Pieter Depuydt, Simon Feys, Greet Hermans, Oscar Hoiting, Ben van der Hoven, Cato Jacobs, Katrien Lagrou, Virginie Lemiale, Piet Lormans, Johan Maertens, Philippe Meersseman, Bruno Mégarbane, Saad Nseir, Jos A. H. van Oers, Marijke Reynders, Bart J. A. Rijnders, Jeroen A. Schouten, Isabel Spriet, Karin Thevissen, Arnaud W. Thille, Ruth Van Daele, Frank L. van de Veerdonk, Paul E. Verweij, Alexander Wilmer, Roger J. M. Brüggemann, Joost Wauters, [missing] the Dutch-Belgian Mycosis Study Group, Alexander Schauwvlieghe, and Tom Wolfs. 2021. “Posaconazole for Prevention of Invasive Pulmonary Aspergillosis in Critically Ill Influenza Patients (POSA-FLU) : A Randomised, Open-Label, Proof-of-Concept Trial.” INTENSIVE CARE MEDICINE 47 (6): 674–686. doi:10.1007/s00134-021-06431-0.
Vancouver
1.
Vanderbeke L, Janssen NAF, Bergmans DCJJ, Bourgeois M, Buil JB, Debaveye Y, et al. Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU) : a randomised, open-label, proof-of-concept trial. INTENSIVE CARE MEDICINE. 2021;47(6):674–86.
IEEE
[1]
L. Vanderbeke et al., “Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU) : a randomised, open-label, proof-of-concept trial,” INTENSIVE CARE MEDICINE, vol. 47, no. 6, pp. 674–686, 2021.
@article{8717307,
  abstract     = {{Purpose Influenza-associated pulmonary aspergillosis (IAPA) is a frequent complication in critically ill influenza patients, associated with significant mortality. We investigated whether antifungal prophylaxis reduces the incidence of IAPA. Methods We compared 7 days of intravenous posaconazole (POS) prophylaxis with no prophylaxis (standard-of-care only, SOC) in a randomised, open-label, proof-of-concept trial in patients admitted to an intensive care unit (ICU) with respiratory failure due to influenza (ClinicalTrials.gov, NCT03378479). Adult patients with PCR-confirmed influenza were block randomised (1:1) within 10 days of symptoms onset and 48 h of ICU admission. The primary endpoint was the incidence of IAPA during ICU stay in patients who did not have IAPA within 48 h of ICU admission (modified intention-to-treat (MITT) population). Results Eighty-eight critically ill influenza patients were randomly allocated to POS or SOC. IAPA occurred in 21 cases (24%), the majority of which (71%, 15/21) were diagnosed within 48 h of ICU admission, excluding them from the MITT population. The incidence of IAPA was not significantly reduced in the POS arm (5.4%, 2/37) compared with SOC (11.1%, 4/36; between-group difference 5.7%; 95% CI - 10.8 to 21.7; p = 0.32). ICU mortality of early IAPA was high (53%), despite rapid antifungal treatment. Conclusion The higher than expected incidence of early IAPA precludes any definite conclusion on POS prophylaxis. High mortality of early IAPA, despite timely antifungal therapy, indicates that alternative management strategies are required. After 48 h, still 11% of patients developed IAPA. As these could benefit from prophylaxis, differentiated strategies are likely needed to manage IAPA in the ICU.}},
  author       = {{Vanderbeke, Lore and Janssen, Nico A. F. and Bergmans, Dennis C. J. J. and Bourgeois, Marc and Buil, Jochem B. and Debaveye, Yves and Depuydt, Pieter and Feys, Simon and Hermans, Greet and Hoiting, Oscar and van der Hoven, Ben and Jacobs, Cato and Lagrou, Katrien and Lemiale, Virginie and Lormans, Piet and Maertens, Johan and Meersseman, Philippe and Mégarbane, Bruno and Nseir, Saad and van Oers, Jos A. H. and Reynders, Marijke and Rijnders, Bart J. A. and Schouten, Jeroen A. and Spriet, Isabel and Thevissen, Karin and Thille, Arnaud W. and Van Daele, Ruth and van de Veerdonk, Frank L. and Verweij, Paul E. and Wilmer, Alexander and Brüggemann, Roger J. M. and Wauters, Joost and the Dutch-Belgian Mycosis Study Group, [missing] and Schauwvlieghe, Alexander and Wolfs, Tom}},
  issn         = {{0342-4642}},
  journal      = {{INTENSIVE CARE MEDICINE}},
  keywords     = {{Critical Care and Intensive Care Medicine,Aspergillosis,Influenza,Posaconazole,Critical illness,Prophylaxis,AZOLE RESISTANCE,PROPHYLAXIS,SURVEILLANCE,FLUCONAZOLE,FUMIGATUS,VIRUS}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{674--686}},
  title        = {{Posaconazole for prevention of invasive pulmonary aspergillosis in critically ill influenza patients (POSA-FLU) : a randomised, open-label, proof-of-concept trial}},
  url          = {{http://doi.org/10.1007/s00134-021-06431-0}},
  volume       = {{47}},
  year         = {{2021}},
}
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