CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 154 enrolled
Drug / intervention
Levofloxacindrug
Likely dose
Levofloxacin 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01353339
NCT01353339Phase 4Completed
CompareCT.gov

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

Ottawa Hospital Research Institute·interventional·Posted May 13, 2011·Updated Apr 5, 2024

In Brief

A Phase 4 clinical trial evaluating Levofloxacin for Disease Due to BK Polyomavirus and Kidney Transplant Infection. Completed, enrolled 154 participants across 11 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisease Due to BK Polyomavirus, Kidney Transplant Infection
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR), St. Paul's Hospital, Canada, Vancouver General Hospital, University of Alberta, University of Manitoba, University Health Network, Toronto, Unity Health Toronto, St. Joseph's Healthcare Hamilton, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, Dalhousie University

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 13, 2011
Enrollment StartDec 1, 2011
Primary CompletionFeb 25, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.1 years ago

Interventions

Levofloxacindrug

500mg, PO, once daily for 3 months