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Original Investigation
November 26, 2014

Levofloxacin for BK Virus Prophylaxis Following Kidney Transplantation: A Randomized Clinical Trial

Author Affiliations
  • 1Division of Nephrology, Kidney Research Centre, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  • 2Clinical Epidemiology Program, Ottawa Hospital Research Institute, and Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
  • 3Department of Medicine, Toronto General Hospital, University of Toronto, Ontario, Canada
  • 4Department of Medicine, Vancouver General Hospital, Vancouver, British Columbia, Canada
  • 5Department of Medicine, Western University and London Health Sciences Centre, London, Ontario, Canada
  • 6Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Canada
  • 7Department of Medicine, St Michael’s Hospital, Toronto, Ontario, Canada
  • 8Department of Medicine, University of Alberta, Edmonton, Canada
  • 9Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada
  • 10Department of Medicine, University of Manitoba, Winnipeg, Canada
  • 11Department of Medicine, St Paul’s Hospital, Vancouver, British Columbia, Canada
  • 12Center for Health Evaluation and Outcomes Sciences, University of British Columbia, Vancouver, British Columbia, Canada
  • 13Tufts–New England Medical Center, Boston, Massachusetts
JAMA. 2014;312(20):2106-2114. doi:10.1001/jama.2014.14721

Importance  BK virus infection is a significant complication of modern immunosuppression used in kidney transplantation. Viral reactivation occurs first in the urine (BK viruria) and is associated with a high risk of transplant failure. There are currently no therapies to prevent or treat BK virus infection. Quinolone antibiotics have antiviral properties against BK virus but efficacy at preventing this infection has not been shown in prospective controlled studies.

Objective  To determine if levofloxacin can prevent BK viruria in kidney transplant recipients.

Design, Setting, and Participants  Double-blind, placebo-controlled randomized trial involving 154 patients who received a living or deceased donor kidney-only transplant in 7 Canadian transplant centers between December 2011 and June 2013.

Interventions  Participants were randomly assigned to receive a 3-month course of levofloxacin (500 mg/d; n = 76) or placebo (n = 78) starting within 5 days after transplantation.

Main Outcomes and Measures  The primary outcome was time to occurrence of BK viruria (detected using quantitative real-time polymerase chain reaction) within the first year after transplantation. Secondary outcomes included BK viremia, peak viral load, rejection, and patient and allograft survival.

Results  The mean follow-up time was 46.5 weeks in the levofloxacin group and 46.3 weeks in the placebo group (27 patients had follow-up terminated before the end of the planned follow-up period or development of viruria because the trial was stopped early owing to lack of funding). BK viruria occurred in 22 patients (29%) in the levofloxacin group and in 26 patients (33.3%) in the placebo group (hazard ratio, 0.91; 95% CI, 0.51-1.63; P = .58). There was no significant difference between the 2 groups in regard to any of the secondary end points. There was an increased risk of resistant infection among isolates usually sensitive to quinolones in the levofloxacin group vs placebo (14/24 [58.3%] vs 15/45 [33.3%], respectively; risk ratio, 1.75; 95% CI, 1.01-2.98) as well as a nonsignificant increased risk of suspected tendinitis (6/76 [7.9%] vs 1/78 [1.3%]; risk ratio, 6.16; 95% CI, 0.76-49.95).

Conclusions and Relevance  Among kidney transplant recipients, a 3-month course of levofloxacin initiated early following transplantation did not prevent BK viruria. Levofloxacin was associated with an increased risk of adverse events such as bacterial resistance. These findings do not support the use of levofloxacin to prevent posttransplant BK virus infection.

Trial Registration  clinicaltrials.gov Identifier: NCT01353339