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

NCT01353339 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-04-05

Study results available
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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

Conditions

  • Disease Due to BK Polyomavirus
  • Kidney Transplant Infection

Interventions

DRUG

Levofloxacin

500mg, PO, once daily for 3 months

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • St. Paul's Hospital, Canada

    collaborator OTHER

  • Vancouver General Hospital

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • University of Manitoba

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • London Health Sciences Centre

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Greg Knoll, MD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2014-02-25
Completion
2014-02-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01353339 on ClinicalTrials.gov