Efficacy of levofloxacin in the treatment of BK viremia: a multicenter,
double-blinded, randomized, placebo-controlled trial.
Author(s): Lee BT(1), Gabardi S, Grafals M, Hofmann RM, Akalin E, Aljanabi A, Mandelbrot DA,
Adey DB, Heher E, Fan PY, Conte S, Dyer-Ward C, Chandraker A.
Affiliation(s): Author information:
(1)Due to the number of contributing authors, the affiliations are provided in the
Supplemental Material.
Publication date & source: 2014, Clin J Am Soc Nephrol. , 9(3):583-9
BACKGROUND AND OBJECTIVES: BK virus reactivation in kidney transplant recipients
can lead to progressive allograft injury. Reduction of immunosuppression remains
the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics
are known to have in vitro antiviral properties, but the evidence for their use
in patients with BK viremia is inconclusive. The objective of the study was to
determine the efficacy of levofloxacin in the treatment of BK viremia.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Enrollment in this prospective,
multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to
March 2012. Thirty-nine kidney transplant recipients with BK viremia were
randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days.
Immunosuppression in all patients was adjusted on the basis of standard clinical
practices at each institution. Plasma BK viral load and serum creatinine were
measured monthly for 3 months and at 6 months.
RESULTS: At the 3-month follow-up, the percentage reductions in BK viral load
were 70.3% and 69.1% in the levofloxacin group and the placebo group,
respectively (P=0.93). The percentage reductions in BK viral load were also
equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus
90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed
no difference in allograft function between the two study groups during the
follow-up period.
CONCLUSIONS: A 30-day course of levofloxacin does not significantly improve BK
viral load reduction or allograft function when used in addition to overall
reduction of immunosuppression.
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