Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
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| ClinicalTrials.gov Identifier: NCT01353339 |
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Recruitment Status
:
Completed
First Posted
: May 13, 2011
Last Update Posted
: October 15, 2014
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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 |
| 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 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: sugar pill |
Drug: Levofloxacin
500mg, PO, once daily for 3 months
Other Names:
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| Active Comparator: levofloxacin |
Drug: Levofloxacin
500mg, PO, once daily for 3 months
Other Names:
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- 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
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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.
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 | |
| Principal Investigator: | Greg Knoll, MD | Ottawa Hospital Research Institute |
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:
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Kidney Transplant BK Polyomavirus Infection |
Additional relevant MeSH terms:
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Infection Communicable Diseases Virus Diseases Levofloxacin Ofloxacin 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 |