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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01353339
Other study ID # CIHR MOP 222493, 2010-292
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2011
Est. completion date February 25, 2014

Study information

Verified date October 2014
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date February 25, 2014
Est. primary completion date February 25, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Levofloxacin
500mg, PO, once daily for 3 months

Locations

Country Name City State
Canada Capital Health - University of Alberta Hospital Edmonton Alberta
Canada QEII Health Science Center Halifax Nova Scotia
Canada St. Joseph's Healthcare Hamilton Ontario
Canada London Health Science Center London Ontario
Canada McGill University Health Center Montreal Quebec
Canada The Ottawa Hospital Ottawa Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada University Health Network Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
Canada Winnipeg Health Science Center Winnipeg Manitoba

Sponsors (12)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Canadian Institutes of Health Research (CIHR), Dalhousie University, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, St. Joseph's Healthcare Hamilton, St. Paul's Hospital, Canada, Unity Health Toronto, University Health Network, Toronto, University of Alberta, University of Manitoba, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Adverse Events Incidence and type of all adverse events 12 months
Secondary Acute Rejection Incidence of Acute rejection 12 months
Secondary Clostridium Difficile Associated Diarrhea Incidence of microbiologically confirmed clostridium difficile associated diarrhea 12 months
Secondary Infections Incidence of other infections (viral, bacterial and fungal) based on established guidelines 12 months
Secondary Quinolone Resistance Incidence of quinolone resistance where a quinolone would have been a therapeutic option 12 months
Secondary Allograft Loss Absence of kidney function in allograft 12 months
Secondary Mortality 12 months
Secondary Adherence Proportion of randomized participants who are adherent to the protocol. 12 months
Secondary Use of Quinolones Use of quinolones outside of the protocol 12 months
Secondary Proportion of Patient Drop-out and Loss to Follow-up 12 months
Secondary Quantitative BK Urine Viral Load 12 months
Secondary BK Viremia BK viremia defined as =250 copies/mL of BK virus DNA in the plasma 12 months
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