Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
43 participants
INTERVENTIONAL
2009-02-28
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Levofloxacin
Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
levofloxacin
500 mg tablet, daily, 30 days
placebo
placebo identical to levofloxacin drug daily for 30 days
placebo
no dose, tablet, daily, 30 days
Interventions
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levofloxacin
500 mg tablet, daily, 30 days
placebo
no dose, tablet, daily, 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with active infections, history of malignancy/Posttransplant Lymphoproliferative Disease (PTLD) serologic positivity to HIV.
* Patients with evidence of urinary tract obstruction causing allograft dysfunction, unless corrected by time of enrollment.
* Patients with clinical or morphological evidence of recurrence of primary disease.
* Patients with a history of allergic reaction to quinolone antibiotics.
* Patients with history of prolong QT interval
* Patients with recurrent hypoglycemic episodes
* Patients with history of myasthenia gravis
* Patients taking Thioridazine
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Anil K. Chandraker, MD
Medical Director of Renal Transplantation
Principal Investigators
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Anil Chandraker, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Countries
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References
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Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.
Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. doi: 10.1086/497080. No abstract available.
Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
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. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. Clin J Am Soc Nephrol. 2014 Mar;9(3):583-9. doi: 10.2215/CJN.04230413. Epub 2014 Jan 30.
Other Identifiers
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2009p000020
Identifier Type: -
Identifier Source: org_study_id
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