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
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
|Condition or disease||Intervention/treatment||Phase|
|Disease Due to BK Polyomavirus Kidney Transplant Infection||Drug: Levofloxacin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||October 2014|
|Placebo Comparator: sugar pill||
500mg, PO, once daily for 3 months
|Active Comparator: levofloxacin||
500mg, PO, once daily for 3 months
- 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.
- 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
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
|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|
|Winnipeg Health Science Center|
|Winnipeg, Manitoba, Canada|
|Canada, Nova Scotia|
|QEII Health Science Center|
|Halifax, Nova Scotia, Canada|
|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|
|McGill University Health Center|
|Montreal, Quebec, Canada, H3A 1A1|
|Principal Investigator:||Greg Knoll, MD||Ottawa Hospital Research Institute|