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Article Dans Une Revue Annals of Intensive Care Année : 2021

Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation

Sophie Cayot-Constantin
  • Fonction : Auteur
Boris Jung
Bertrand Souweine
  • Fonction : Auteur
Carole Schwebel
  • Fonction : Auteur
Jérôme Allardet-Servent
  • Fonction : Auteur
Toufik Kamel
  • Fonction : Auteur
Qin Lu
  • Fonction : Auteur
Anderson Loundou
Christine Penot-Ragon
  • Fonction : Auteur
Jean-Marie Forel

Résumé

Background: The effect of cytomegalovirus (CMV) reactivation on the length of mechanical ventilation and mortality in immunocompetent ICU patients requiring invasive mechanical ventilation remains controversial. The main objective of this study was to determine whether preemptive intravenous ganciclovir increases the number of ventilatorfree days in patients with CMV blood reactivation. Methods: This double-blind, placebo-controlled, randomized clinical trial involved 19 ICUs in France. Seventy-six adults ≥ 18 years old who had been mechanically ventilated for at least 96 h, expected to remain on mechanical ventilation for ≥ 48 h, and exhibited reactivation of CMV in blood were enrolled between February 5th, 2014, and January 23rd, 2019. Participants were randomized to receive ganciclovir 5 mg/kg bid for 14 days (n = 39) or a matching placebo (n = 37). Results: The primary endpoint was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included day 60 mortality. The trial was stopped for futility based on the results of an interim analysis by the DSMB. The subdistribution hazard ratio for being alive and weaned from mechanical ventilation at day 60 for patients receiving ganciclovir (N = 39) compared with control patients (N = 37) was 1.14 (95% CI from 0.63 to 2.06; P = 0.66). The median [IQR] numbers of ventilator-free days for ganciclovir-treated patients and controls were 10 [0-51] and 0 [0-43] days, respectively (P = 0.46). Mortality at day 60 was 41% in patients in the ganciclovir group and 43% in the placebo group (P = .845). Creatinine levels and blood cells counts did not differ significantly between the two groups. Conclusions: In patients mechanically ventilated for ≥ 96 h with CMV reactivation in blood, preemptive ganciclovir did not improve the outcome.
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hal-03140061 , version 1 (22-03-2021)

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Laurent Papazian, Samir Jaber, Sami Hraiech, Karine Baumstarck, Sophie Cayot-Constantin, et al.. Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation. Annals of Intensive Care, 2021, 11 (1), pp.33. ⟨10.1186/s13613-020-00793-2⟩. ⟨hal-03140061⟩
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