NCT01353339

Brief Summary

Primary Research Questions: Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.

  1. 1.Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load.
  2. 2.Under safety, this pilot will determine the incidence of adverse events with levofloxacin.
  3. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2014

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

April 5, 2024

Completed
Last Updated

April 5, 2024

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

May 11, 2011

Results QC Date

November 17, 2022

Last Update Submit

October 11, 2023

Conditions

Disease Due to BK PolyomavirusKidney Transplant Infection

Keywords

Kidney TransplantBK Polyomavirus Infection

Outcome Measures

Primary Outcomes (1)

  • Occurrence of BK Viruria

    BK viruria was defined as 500 copies/mL or more of BK virus DNA in the urine.

    12 months post-transplantation

Secondary Outcomes (12)

  • Adverse Events

    12 months

  • Acute Rejection

    12 months

  • Clostridium Difficile Associated Diarrhea

    12 months

  • Infections

    12 months

  • Quinolone Resistance

    12 months

  • +7 more secondary outcomes

Study Arms (2)

sugar pill

PLACEBO COMPARATOR
Drug: Levofloxacin

levofloxacin

ACTIVE COMPARATOR
Drug: Levofloxacin

Interventions

LevofloxacinDRUG

500mg, PO, once daily for 3 months

Also known as: Apo-levofloxacin, DIN 02284707
levofloxacinsugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a primary or repeat kidney transplant recipient (deceased or living donor)
  • age greater or equal to 18 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Capital Health - University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Winnipeg Health Science Center

Winnipeg, Manitoba, Canada

Location

QEII Health Science Center

Halifax, Nova Scotia, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Science Center

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (3)

  • Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

    PMID: 39382091DERIVED

  • Knoll GA, Humar A, Fergusson D, Johnston O, House AA, Kim SJ, Ramsay T, Chasse M, Pang X, Zaltzman J, Cockfield S, Cantarovich M, Karpinski M, Lebel L, Gill JS. Levofloxacin for BK virus prophylaxis following kidney transplantation: a randomized clinical trial. JAMA. 2014 Nov 26;312(20):2106-14. doi: 10.1001/jama.2014.14721.

    PMID: 25399012DERIVED

  • Humar A, Gill J, Johnston O, Fergusson D, House AA, Lebel L, Cockfield S, Kim SJ, Zaltzman J, Cantarovich M, Karpinski M, Ramsay T, Knoll GA. Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial. Trials. 2013 Jun 21;14:185. doi: 10.1186/1745-6215-14-185.

    PMID: 23800312DERIVED

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. John S. Gill
Organization
St Paul's Hospital
jgill@providencehealth.bc.ca
604-806-8970

Study Officials

  • Greg Knoll, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 13, 2011

Study Start

December 1, 2011

Primary Completion

February 25, 2014

Study Completion

February 25, 2014

Last Updated

April 5, 2024

Results First Posted

April 5, 2024

Record last verified: 2014-10

Locations

CA(11)