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Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01353339
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : October 15, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Research Questions:

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

Condition or disease Intervention/treatment Phase
Disease Due to BK Polyomavirus Kidney Transplant Infection Drug: Levofloxacin Phase 4

Detailed Description:

BK virus infection has emerged as a major complication in renal transplantation leading to a significant reduction in graft survival. There are currently no proven strategies to prevent or treat BK virus infection. Quinolone antibiotics, such as levofloxacin, have demonstrated activity against BK virus. The investigators hypothesize that administration of a quinolone antibiotic, when given early post-transplantation, will prevent the establishment of BK viral replication in the urine and thus prevent systemic BK virus infection. A non-randomized study in kidney transplant recipients found that patients given levofloxacin or ciprofloxacin had a significantly lower incidence of BK viremia compared to those not receiving a quinolone (4% versus 24.5%, P=0.02).

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
Study Start Date : November 2011
Primary Completion Date : April 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: sugar pill Drug: Levofloxacin
500mg, PO, once daily for 3 months
Other Names:
  • Apo-levofloxacin
  • DIN 02284707
Active Comparator: levofloxacin Drug: Levofloxacin
500mg, PO, once daily for 3 months
Other Names:
  • Apo-levofloxacin
  • DIN 02284707

Outcome Measures

Primary Outcome Measures :
  1. Efficacy: The time to occurence of BK viruria [ Time Frame: 12 months post-transplantation ]
    BK viruria will be defined as ≥1000 copies/mL ok BK virus DNA in the urine.

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    Incidence and type of all adverse events

  2. Acute rejection [ Time Frame: 12 months ]
    Incidence of Acute rejection

  3. Clostridium difficile associated diarrhea [ Time Frame: 12 months ]
    Incidence of microbiologically confirmed clostridium difficile associated diarrhea

  4. Infections [ Time Frame: 12 months ]
    Incidence of other infections (viral, bacterial and fungal) based on established guidelines

  5. Quinolone resistance [ Time Frame: 12 months ]
    Incidence of quinolone resistance where a quinolone would have been a therapeutic option

  6. Effect of levofloxacin on immunosuppressive drug doses and blood levels [ Time Frame: 12 months ]
  7. Transplant failure [ Time Frame: 12 months ]
  8. Mortality [ Time Frame: 12 months ]
  9. Number of patients transplanted [ Time Frame: 12 months ]
    Number of patients transplanted during the 8 month recruitment period who are randomized into the trial

  10. Adherence [ Time Frame: 12 months ]
    Proportion of randomized participants who are adherent to the protocol.

  11. Use of quinolones [ Time Frame: 12 months ]
    Use of quinolones outside of the protocol

  12. Proportion of patient drop-out and loss to follow-up [ Time Frame: 12 months ]
  13. Quantitative BK urine viral load [ Time Frame: 12 months ]
  14. BK viremia [ Time Frame: 12 months ]
    Time to occurence of BK viremia, defined as ≥250 copies/mL of BK virus DNA in the plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a primary or repeat kidney transplant recipient (deceased or living donor)
  • age greater or equal to 18 years

Exclusion Criteria:

  • Unable to provide informed consent
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353339

Canada, Alberta
Capital Health - University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg Health Science Center
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
QEII Health Science Center
Halifax, Nova Scotia, Canada
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
London Health Science Center
London, Ontario, Canada, N6A 5A5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
University Health Network
Toronto, Ontario, Canada, M5G 2N2
St. Michael's Hospital
Toronto, Ontario, Canada
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
St. Paul's Hospital, Canada
Vancouver General Hospital
University of Alberta
University of Manitoba
University Health Network, Toronto
St. Michael's Hospital, Toronto
St. Joseph's Healthcare Hamilton
London Health Sciences Centre
McGill University Health Center
Dalhousie University
Principal Investigator: Greg Knoll, MD Ottawa Hospital Research Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01353339     History of Changes
Other Study ID Numbers: CIHR MOP 222493, 2010-292
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by Ottawa Hospital Research Institute:
Kidney Transplant
BK Polyomavirus Infection

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors