Efficacy of levofloxacin in the treatment of BK viremia: A multicenter, double-blinded, randomized, placebo-controlled trial

Belinda T. Lee, Steven Gabardi, Monica Grafals, R. Michael Hofmann, Enver Akalin, Aws Aljanabi, Didier A. Mandelbrot, Deborah B. Adey, Eliot Heher, Pang Yen Fan, Sarah Conte, Christine Dyer-Ward, Anil Chandraker

Research output: Contribution to journalArticle

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Abstract

Background and objectives BKvirus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction ofimmunosuppression remains the cornerstone of treatment for activeBKinfection. 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 fromJuly 2009 toMarch 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 patientswas 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 loadwere 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.

Original languageEnglish (US)
Pages (from-to)583-589
Number of pages7
JournalClinical Journal of the American Society of Nephrology
Volume9
Issue number3
DOIs
StatePublished - Mar 7 2014
Externally publishedYes

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Levofloxacin
Viremia
Randomized Controlled Trials
Viral Load
Placebos
Allografts
Immunosuppression
Creatinine
Kidney
Fluoroquinolones
Therapeutics
Serum
Antiviral Agents
Linear Models
Regression Analysis
Anti-Bacterial Agents
Wounds and Injuries
Transplant Recipients

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

Efficacy of levofloxacin in the treatment of BK viremia : A multicenter, double-blinded, randomized, placebo-controlled trial. / Lee, Belinda T.; Gabardi, Steven; Grafals, Monica; Hofmann, R. Michael; Akalin, Enver; Aljanabi, Aws; Mandelbrot, Didier A.; Adey, Deborah B.; Heher, Eliot; Fan, Pang Yen; Conte, Sarah; Dyer-Ward, Christine; Chandraker, Anil.

In: Clinical Journal of the American Society of Nephrology, Vol. 9, No. 3, 07.03.2014, p. 583-589.

Research output: Contribution to journalArticle

Lee, BT, 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 2014, 'Efficacy of levofloxacin in the treatment of BK viremia: A multicenter, double-blinded, randomized, placebo-controlled trial', Clinical Journal of the American Society of Nephrology, vol. 9, no. 3, pp. 583-589. https://doi.org/10.2215/CJN.04230413
Lee, Belinda T. ; Gabardi, Steven ; Grafals, Monica ; Hofmann, R. Michael ; Akalin, Enver ; Aljanabi, Aws ; Mandelbrot, Didier A. ; Adey, Deborah B. ; Heher, Eliot ; Fan, Pang Yen ; Conte, Sarah ; Dyer-Ward, Christine ; Chandraker, Anil. / Efficacy of levofloxacin in the treatment of BK viremia : A multicenter, double-blinded, randomized, placebo-controlled trial. In: Clinical Journal of the American Society of Nephrology. 2014 ; Vol. 9, No. 3. pp. 583-589.
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title = "Efficacy of levofloxacin in the treatment of BK viremia: A multicenter, double-blinded, randomized, placebo-controlled trial",
abstract = "Background and objectives BKvirus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction ofimmunosuppression remains the cornerstone of treatment for activeBKinfection. 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 fromJuly 2009 toMarch 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 patientswas 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 loadwere 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.",
author = "Lee, {Belinda T.} and Steven Gabardi and Monica Grafals and Hofmann, {R. Michael} and Enver Akalin and Aws Aljanabi and Mandelbrot, {Didier A.} and Adey, {Deborah B.} and Eliot Heher and Fan, {Pang Yen} and Sarah Conte and Christine Dyer-Ward and Anil Chandraker",
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T1 - Efficacy of levofloxacin in the treatment of BK viremia

T2 - A multicenter, double-blinded, randomized, placebo-controlled trial

AU - Lee, Belinda T.

AU - Gabardi, Steven

AU - Grafals, Monica

AU - Hofmann, R. Michael

AU - Akalin, Enver

AU - Aljanabi, Aws

AU - Mandelbrot, Didier A.

AU - Adey, Deborah B.

AU - Heher, Eliot

AU - Fan, Pang Yen

AU - Conte, Sarah

AU - Dyer-Ward, Christine

AU - Chandraker, Anil

PY - 2014/3/7

Y1 - 2014/3/7

N2 - Background and objectives BKvirus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction ofimmunosuppression remains the cornerstone of treatment for activeBKinfection. 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 fromJuly 2009 toMarch 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 patientswas 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 loadwere 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.

AB - Background and objectives BKvirus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction ofimmunosuppression remains the cornerstone of treatment for activeBKinfection. 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 fromJuly 2009 toMarch 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 patientswas 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 loadwere 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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