Clinical Trial: Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
Brief Summary:
Primary Research Questions:
Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.
- Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load.
- Under safety, this pilot will determine the incidence of adverse events with levofloxacin.
- 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
Detailed Summary:
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.
Sponsor: Ottawa Hospital Research Institute
Current Primary Outcome: Efficacy: The time to occurence of BK viruria [ Time Frame: 12 months post-transplantation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adverse Events [ Time Frame: 12 months ]Incidence and type of all adverse events
- Acute rejection [ Time Frame: 12 months ]Incidence of Acute rejection
- Clostridium difficile associated diarrhea [ Time Frame: 12 months ]Incidence of microbiologically confirmed clostridium difficile associated diarrhea
- Infections [ Time Frame: 12 months ]Incidence of other infections (viral, bacterial and fungal) based on established guidelines
- Quinolone resistance [ Time Frame: 12 months ]Incidence of quinolone resistance where a quinolone would have been a therapeutic option
- Effect of levofloxacin on immunosuppressive drug doses and blood levels [ Time Frame: 12 months ]
- Transplant failure [ Time Frame: 12 months ]
- Mortality [ Time Frame: 12 months ]
- Number of patients transplanted [ Time Frame: 12 months ]Number of patients transplanted during the 8 month recruitment period who are randomized into the trial
- Adherence [ Time Frame: 12 months ]Proportion of randomized participants who are adherent to the protocol.
- Use of quinolones [ Time Frame: 12 months ]Use of quinolones outside of the protocol
- Proportion of patient drop-out and loss to follow-up [ Time Frame: 12 months ]
- Quantitative BK urine viral load [ Time Frame: 12 months ]
- BK viremia [ Time Frame: 12 months ]Time to occurence of BK viremia, defined as ≥250 copies/mL of BK virus DNA in the plasma
Original Secondary Outcome:
- Adverse Events [ Time Frame: 12 months ]Incidence and type of all adverse events
- Acute rejection [ Time Frame: 12 months ]Incidence of Acute rejection
- Clostridium difficile associated diarrhea [ Time Frame: 12 months ]Incidence of microbiologically confirmed clostridium difficile associated diarrhea
- Infections [ Time Frame: 12 months ]Incidence of other infections (viral, bacterial and fungal) based on establised guidelines
- Quinolone resistance [ Time Frame: 12 months ]Incidence of quinolone resistance where a quinolone would have been a therapeutic option
- Effect of levofloxacin on immunosuppressive drug doses and blood levels [ Time Frame: 12 months ]
- Transplant failure [ Time Frame: 12 months ]
- Mortality [ Time Frame: 12 months ]
- Number of patients transplanted [ Time Frame: 12 months ]Number of patients transplanted during the 8 month recruitment period who are randomized into the trial
- Adherence [ Time Frame: 12 months ]Proportion of randomized participants who are adherent to the protocol.
- Use of quinolones [ Time Frame: 12 months ]Use of quinolones outside of the protocol
- Proportion of patient drop-out and loss to follow-up [ Time Frame: 12 months ]
- Quantitative BK urine viral load [ Time Frame: 12 months ]
- BK viremia [ Time Frame: 12 months ]Time to occurence of BK viremia, defined as ≥250 copies/mL of BK virus DNA in the plasma
Information By: Ottawa Hospital Research Institute
Dates:
Date Received: May 11, 2011
Date Started: November 2011
Date Completion:
Last Updated: October 14, 2014
Last Verified: October 2014
