Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
NCT ID: NCT01353339
Last Updated: 2024-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
154 participants
INTERVENTIONAL
2011-12-01
2014-02-25
Brief Summary
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Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.
1. Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load.
2. Under safety, this pilot will determine the incidence of adverse events with levofloxacin.
3. Under feasibility, this pilot will determine the number of kidney transplant patients randomized over an eight month enrolment period, adherence to the levofloxacin and frequency of patient drop-out and loss to follow-up
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Detailed Description
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Objective: The primary objective of the full trial will be to determine if the quinolone levofloxacin decreases the occurrence of doubling creatinine, transplant failure or death in kidney transplant recipients. The aim of this pilot trial is to assess the efficacy, safety and feasibility of a 3-month course of levofloxacin in the kidney transplant population.
Results from this pilot study will provide vital information to design and conduct a large, multi-centre trial to determine if quinolone therapy decreases meaningful clinical outcomes in kidney transplantation. If levofloxacin significantly reduces BK viruria and urine viral loads in kidney transplantation it will provide important justification of biologic effect to progress to the larger trial. If the full trial shows that levofloxacin significantly reduces BK infection and improves outcomes, its use in renal transplantation will be strongly endorsed given the lack of proven therapies for this condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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sugar pill
Levofloxacin
500mg, PO, once daily for 3 months
levofloxacin
Levofloxacin
500mg, PO, once daily for 3 months
Interventions
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Levofloxacin
500mg, PO, once daily for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age greater or equal to 18 years
Exclusion Criteria
* Greater than 5 days post-transplantation
* BK virus nephropathy with a previous transplant
* History of allergic reaction to any quinolone antibiotic
* History of quinolone associated tendonitis or tendon rupture
* Corrected QT interval prolongation on EKG as defined by Al-Khatib
* Concomitant use of medication known to prolong the QT interval such as class IA antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmic drugs (e.g. amiodarone, sotalol), azole antifungals (e.g. fluconazole) or macrolide antibiotics (e.g. erythromycin)
* Pregnant or breastfeeding as safety of levofloxacin not established
* Requires quinolone antibiotic for more than 14 days (e.g. for UTI prophylaxis)
* Recipient of a multi-organ transplant (e.g. kidney-pancreas)
* Currently enrolled in another interventional trial
* Previously enrolled in this study
* History of rhabdomyolysis
* Significant allergic reaction to ≥ 3 classes of antibiotics as these patients may have no other option other than quinolones for routine infection.
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
St. Paul's Hospital, Canada
OTHER
Vancouver General Hospital
OTHER
University of Alberta
OTHER
University of Manitoba
OTHER
University Health Network, Toronto
OTHER
Unity Health Toronto
OTHER
St. Joseph's Healthcare Hamilton
OTHER
London Health Sciences Centre
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Dalhousie University
OTHER
Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Greg Knoll, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Capital Health - University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Winnipeg Health Science Center
Winnipeg, Manitoba, Canada
QEII Health Science Center
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
London Health Science Center
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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References
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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.
Knoll GA, Humar A, Fergusson D, Johnston O, House AA, Kim SJ, Ramsay T, Chasse M, Pang X, Zaltzman J, Cockfield S, Cantarovich M, Karpinski M, Lebel L, Gill JS. Levofloxacin for BK virus prophylaxis following kidney transplantation: a randomized clinical trial. JAMA. 2014 Nov 26;312(20):2106-14. doi: 10.1001/jama.2014.14721.
Humar A, Gill J, Johnston O, Fergusson D, House AA, Lebel L, Cockfield S, Kim SJ, Zaltzman J, Cantarovich M, Karpinski M, Ramsay T, Knoll GA. Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial. Trials. 2013 Jun 21;14:185. doi: 10.1186/1745-6215-14-185.
Other Identifiers
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CIHR MOP 222493, 2010-292
Identifier Type: -
Identifier Source: org_study_id
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