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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Dalhousie University; London Health Sciences Centre; McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre; St. Joseph's Healthcare Hamilton; St. Michael's Hospital, Toronto; St. Paul's Hospital, Canada; Unity Health Toronto; University Health Network, Toronto; University of Alberta; University of Manitoba; Vancouver General Hospital
• Treatments: Levofloxacin; Ofloxacin

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.