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

Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Disease Due to BK Polyomavirus; Kidney Transplant Infection

Intervention: Levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ottawa Hospital Research Institute

Official(s) and/or principal investigator(s):
Greg Knoll, MD, Principal Investigator, Affiliation: Ottawa Hospital Research Institute

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Efficacy: The time to occurence of BK viruria

Secondary outcome:

Adverse Events

Acute rejection

Clostridium difficile associated diarrhea

Infections

Quinolone resistance

Effect of levofloxacin on immunosuppressive drug doses and blood levels

Transplant failure

Mortality

Number of patients transplanted

Adherence

Use of quinolones

Proportion of patient drop-out and loss to follow-up

Quantitative BK urine viral load

BK viremia

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Capital Health - University of Alberta Hospital, Edmonton, Alberta T6G 2B7, Canada

St. Paul's Hospital, Vancouver, British Columbia V6Z 1Y6, Canada

Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada

Winnipeg Health Science Center, Winnipeg, Manitoba, Canada

QEII Health Science Center, Halifax, Nova Scotia, Canada

St. Joseph's Healthcare, Hamilton, Ontario L8N 4A6, Canada

London Health Science Center, London, Ontario N6A 5A5, Canada

The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada

St. Michael's Hospital, Toronto, Ontario, Canada

University Health Network, Toronto, Ontario M5G 2N2, Canada

McGill University Health Center, Montreal, Quebec H3A 1A1, Canada

Additional Information

Starting date: November 2011
Last updated: October 14, 2014

Page last updated: August 23, 2015

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