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Disease Due to BK PolyomavirusPhase 4NCT01353339

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

A Phase 4 study testing Levofloxacin in people with Disease Due to BK Polyomavirus and Kidney Transplant Infection, run by Ottawa Hospital Research Institute at 11 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Levofloxacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
11 sitesCanada
Study dates
1 Dec 2011to 25 Feb 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • Capital Health - University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • QEII Health Science Center

    Halifax, Nova Scotia

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • London Health Science Center

    London, Ontario, N6A 5A5

  • McGill University Health Center

    Montreal, Quebec, H3A 1A1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • St. Michael's Hospital

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Winnipeg Health Science Center

    Winnipeg, Manitoba

Other trials in Canada

About this study

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
Read the 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.

Being tested
Levofloxacin
Keywords
Kidney Transplant, BK Polyomavirus Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevofloxacinDrug

    Also called Apo-levofloxacin, DIN 02284707

    500mg, PO, once daily for 3 months

Study groups in NCT01353339
Study groupRoleWhat they receive
sugar pillPlacebo comparatorNot described
Receives: Drug: Levofloxacin
levofloxacinActive comparatorNot described
Receives: Drug: Levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of BK Viruria

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

    Measured: 12 months post-transplantation

Secondary outcomes (12)

  1. Adverse Events

    Incidence and type of all adverse events

    Measured: 12 months

  2. Acute Rejection

    Incidence of Acute rejection

    Measured: 12 months

  3. Clostridium Difficile Associated Diarrhea

    Incidence of microbiologically confirmed clostridium difficile associated diarrhea

    Measured: 12 months

  4. Infections

    Incidence of other infections (viral, bacterial and fungal) based on established guidelines

    Measured: 12 months

  5. Quinolone Resistance

    Incidence of quinolone resistance where a quinolone would have been a therapeutic option

    Measured: 12 months

  6. Allograft Loss

    Absence of kidney function in allograft

    Measured: 12 months

  7. Mortality

    Measured: 12 months

  8. Adherence

    Proportion of randomized participants who are adherent to the protocol.

    Measured: 12 months

  9. Use of Quinolones

    Use of quinolones outside of the protocol

    Measured: 12 months

  10. Proportion of Patient Drop-out and Loss to Follow-up

    Measured: 12 months

  11. Quantitative BK Urine Viral Load

    Measured: 12 months

  12. BK Viremia

    BK viremia defined as ≥250 copies/mL of BK virus DNA in the plasma

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2011 (estimated)
  2. Study start1 Dec 2011
  3. Primary completion25 Feb 2014
  4. Study completion25 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01353339
Sponsor's protocol ID
CIHR MOP 222493, 2010-292
Status last verified
Oct 2014
First submitted
11 May 2011
Last updated
5 Apr 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39382091

  • 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.

    PubMed 25399012

  • 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.

    PubMed 23800312

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levofloxacin in people with Disease Due to BK Polyomavirus and Kidney Transplant Infection, run by Ottawa Hospital Research Institute at 11 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of BK Viruria (time frame: 12 months post-transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01353339, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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