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Effect of Ganciclovir on IL-6 Levels Among Cytomegalovirus-Seropositive Adults With Critical Illness: A Randomized Clinical Trial.

Abstract The role of cytomegalovirus (CMV) reactivation in mediating adverse clinical outcomes in nonimmunosuppressed adults with critical illness is unknown.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama
Publication Year Start




PMID- 28829877
OWN - NLM
STAT- In-Process
DA  - 20170822
LR  - 20170822
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 8
DP  - 2017 Aug 22
TI  - Effect of Ganciclovir on IL-6 Levels Among Cytomegalovirus-Seropositive Adults
      With Critical Illness: A Randomized Clinical Trial.
PG  - 731-740
LID - 10.1001/jama.2017.10569 [doi]
AB  - Importance: The role of cytomegalovirus (CMV) reactivation in mediating adverse
      clinical outcomes in nonimmunosuppressed adults with critical illness is unknown.
      Objective: To determine whether ganciclovir prophylaxis reduces plasma
      interleukin 6 (IL-6) levels in CMV-seropositive adults who are critically ill.
      Design, Setting, and Participants: Double-blind, placebo-controlled, randomized
      clinical trial (conducted March 10, 2011-April 29, 2016) with a follow-up of 180 
      days (November 10, 2016) that included 160 CMV-seropositive adults with either
      sepsis or trauma and respiratory failure at 14 university intensive care units
      (ICUs) across the United States. Interventions: Patients were randomized (1:1) to
      receive either intravenous ganciclovir (5 mg/kg twice daily for 5 days), followed
      by either intravenous ganciclovir or oral valganciclovir once daily until
      hospital discharge (n = 84) or to receive matching placebo (n = 76). Main
      Outcomes and Measures: The primary outcome was change in IL-6 level from day 1 to
      14. Secondary outcomes were incidence of CMV reactivation in plasma, mechanical
      ventilation days, incidence of secondary bacteremia or fungemia, ICU length of
      stay, mortality, and ventilator-free days (VFDs) at 28 days. Results: Among 160
      randomized patients (mean age, 57 years; women, 43%), 156 patients received 1or
      more dose(s) of study medication, and 132 patients (85%) completed the study. The
      mean change in plasma IL-6 levels between groups was -0.79 log10 units (-2.06 to 
      0.48) in the ganciclovir group and -0.79 log10 units (-2.14 to 0.56) in the
      placebo group (point estimate of difference, 0 [95% CI, -0.3 to 0.3]; P > .99).
      Among secondary outcomes, CMV reactivation in plasma was significantly lower in
      the ganciclovir group (12% [10 of 84 patients] vs 39% [28 of 72 patients]);
      absolute risk difference, -27 (95% CI, -40 to -14), P < .001. The ganciclovir
      group had more median VFDs in both the intention-to-treat (ITT) group and in the 
      prespecified sepsis subgroup (ITT group: 23 days in ganciclovir group vs 20 days 
      in the placebo group, P = .05; sepsis subgroup, 23 days in the ganciclovir group 
      vs 20 days in the placebo group, P = .03). There were no significant differences 
      between the ganciclovir and placebo groups in duration of mechanical ventilation 
      (5 days for the ganciclovir group vs 6 days for the placebo group, P = .16),
      incidence of secondary bacteremia or fungemia (15% for the ganciclovir group vs
      15% for the placebo group, P = .67), ICU length of stay (8 days for the
      ganciclovir group vs 8 days for the placebo group, P = .76), or mortality (12%
      for the ganciclovir group vs 15% for the placebo group, P = .54). Conclusions and
      Relevance: Among CMV-seropositive adults with critical illness due to sepsis or
      trauma, ganciclovir did not reduce IL-6 levels and the current study does not
      support routine clinical use of ganciclovir as a prophylactic agent in patients
      with sepsis. Additional research is necessary to determine the clinical efficacy 
      and safety of CMV suppression in this setting. Trial Registration:
      clinicaltrials.gov Identifier: NCT01335932.
FAU - Limaye, Ajit P
AU  - Limaye AP
AD  - Division of Allergy and Infectious Diseases, University of Washington, Seattle.
FAU - Stapleton, Renee D
AU  - Stapleton RD
AD  - Pulmonary and Critical Care Division, University of Vermont College of Medicine, 
      Burlington.
FAU - Peng, Lili
AU  - Peng L
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington.
FAU - Gunn, Scott R
AU  - Gunn SR
AD  - Critical Care Division, University of Pittsburgh Medical Center, Pittsburgh,
      Pennsylvania.
FAU - Kimball, Louise E
AU  - Kimball LE
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington.
FAU - Hyzy, Robert
AU  - Hyzy R
AD  - Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann
      Arbor.
FAU - Exline, Matthew C
AU  - Exline MC
AD  - Division of Pulmonary, Critical Care and Sleep Medicine, Ohio State University
      Wexner Medical Center, Columbus.
FAU - Files, D Clark
AU  - Files DC
AD  - Department of Pulmonary and Critical Care Medicine, Wake Forest School of
      Medicine, Winston-Salem, North Carolina.
FAU - Morris, Peter E
AU  - Morris PE
AD  - Department of Pulmonary and Critical Care Medicine, Wake Forest School of
      Medicine, Winston-Salem, North Carolina.
FAU - Frankel, Stephen K
AU  - Frankel SK
AD  - Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Sleep
      Center, Denver, Colorado.
FAU - Mikkelsen, Mark E
AU  - Mikkelsen ME
AD  - Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 
      Philadelphia.
FAU - Hite, Duncan
AU  - Hite D
AD  - Department of Critical Care Medicine, Cleveland Clinic, Cleveland, Ohio.
FAU - Enfield, Kyle B
AU  - Enfield KB
AD  - Department of Medicine, University of Virginia, Charlottesville.
FAU - Steingrub, Jay
AU  - Steingrub J
AD  - Division of Critical Care Pulmonary Medicine, Baystate Medical Center,
      Springfield, Massachusetts.
FAU - O'Brien, James
AU  - O'Brien J
AD  - Division of Pulmonary, Critical Care and Sleep Medicine, Ohio State University
      Wexner Medical Center, Columbus.
FAU - Parsons, Polly E
AU  - Parsons PE
AD  - Pulmonary and Critical Care Division, University of Vermont College of Medicine, 
      Burlington.
FAU - Cuschieri, Joseph
AU  - Cuschieri J
AD  - Department of Surgery, University of Washington, Seattle.
FAU - Wunderink, Richard G
AU  - Wunderink RG
AD  - Division of Pulmonary and Critical Care, Northwestern Feinberg School of
      Medicine, Chicago, Illinois.
FAU - Hotchkin, David L
AU  - Hotchkin DL
AD  - Division of Pulmonary and Critical Care Medicine, Oregon Clinic, Portland.
FAU - Chen, Ying Q
AU  - Chen YQ
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington.
FAU - Rubenfeld, Gordon D
AU  - Rubenfeld GD
AD  - Interdepartmental Division of Critical Care Medicine, Sunnybrook Health Sciences 
      Center, Toronto, Ontario, Canada.
FAU - Boeckh, Michael
AU  - Boeckh M
AD  - Division of Allergy and Infectious Diseases, University of Washington, Seattle.
AD  - Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 
      Seattle, Washington.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/08/23 06:00
MHDA- 2017/08/23 06:00
CRDT- 2017/08/23 06:00
AID - 2649189 [pii]
AID - 10.1001/jama.2017.10569 [doi]
PST - ppublish
SO  - JAMA. 2017 Aug 22;318(8):731-740. doi: 10.1001/jama.2017.10569.