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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| St. Paul's Hospital, Canada | OTHER |
| Vancouver General Hospital | OTHER |
| University of Alberta |
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Primary Research Questions:
Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator |
| |
| levofloxacin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | 500mg, PO, once daily for 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence and type of all adverse events | 12 months |
| Acute Rejection | Incidence of Acute rejection | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Knoll, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Health - University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| Vancouver General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382091 | Derived | 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. | |
| 25399012 | Derived | 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. |
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Eligible patients with written informed consent were randomly assigned to receive either levofloxacin or placebo in a 1:1 fashion. Allocation was achieved through web-based central randomization in variable blocks stratified by center. An independent statistician prepared the randomization schemes. Physicians, nurses, investigators, and research staff were blinded to the randomization scheme, and active study medication and matching placebo were identical in appearance
The first patient was randomized on December 1, 2011, and recruitment continued until June 25, 2013. The last patient follow-up visit was February 25, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levofloxacin | Levofloxacin: 500mg, PO, once daily for 3 months |
| FG001 | Sugar Pill | Levofloxacin: 500mg, PO, once daily for 3 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| University of Manitoba | OTHER |
| University Health Network, Toronto | OTHER |
| Unity Health Toronto | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
| London Health Sciences Centre | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Dalhousie University | OTHER |
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| Clostridium Difficile Associated Diarrhea | Incidence of microbiologically confirmed clostridium difficile associated diarrhea | 12 months |
| Infections | Incidence of other infections (viral, bacterial and fungal) based on established guidelines | 12 months |
| Quinolone Resistance | Incidence of quinolone resistance where a quinolone would have been a therapeutic option | 12 months |
| Allograft Loss | Absence of kidney function in allograft | 12 months |
| Mortality | 12 months |
| Adherence | Proportion of randomized participants who are adherent to the protocol. | 12 months |
| Use of Quinolones | Use of quinolones outside of the protocol | 12 months |
| Proportion of Patient Drop-out and Loss to Follow-up | 12 months |
| Quantitative BK Urine Viral Load | 12 months |
| BK Viremia | BK viremia defined as ≥250 copies/mL of BK virus DNA in the plasma | 12 months |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg Health Science Center | Winnipeg | Manitoba | Canada |
| QEII Health Science Center | Halifax | Nova Scotia | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| London Health Science Center | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| McGill University Health Center | Montreal | Quebec | H3A 1A1 | Canada |
| 23800312 | Derived | 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. |
| Discontinued Intervention |
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| Incomplete Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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All participants were randomized in the study and included in baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Levofloxacin | Levofloxacin: 500mg, PO, once daily for 3 months |
| BG001 | Sugar Pill | Levofloxacin: 500mg, PO, once daily for 3 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of BK Viruria | BK viruria was defined as 500 copies/mL or more of BK virus DNA in the urine. | Posted | Count of Participants | Participants | 12 months post-transplantation |
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| Secondary | Adverse Events | Incidence and type of all adverse events | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Acute Rejection | Incidence of Acute rejection | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Clostridium Difficile Associated Diarrhea | Incidence of microbiologically confirmed clostridium difficile associated diarrhea | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Infections | Incidence of other infections (viral, bacterial and fungal) based on established guidelines | Posted | Mean | Standard Deviation | Number of infections per patient | 12 months |
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| Secondary | Quinolone Resistance | Incidence of quinolone resistance where a quinolone would have been a therapeutic option | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Allograft Loss | Absence of kidney function in allograft | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Mortality | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Adherence | Proportion of randomized participants who are adherent to the protocol. | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Use of Quinolones | Use of quinolones outside of the protocol | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Proportion of Patient Drop-out and Loss to Follow-up | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Quantitative BK Urine Viral Load | Posted | Mean | Standard Deviation | copies/mL | 12 months |
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| Secondary | BK Viremia | BK viremia defined as ≥250 copies/mL of BK virus DNA in the plasma | Posted | Count of Participants | Participants | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levofloxacin | Levofloxacin: 500mg, PO, once daily for 3 months | 0 | 76 | 6 | 76 | 76 | 76 |
| EG001 | Sugar Pill | Levofloxacin: 500mg, PO, once daily for 3 months | 0 | 78 | 1 | 78 | 78 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tendinitis | Musculoskeletal and connective tissue disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Over 1 infection | Infections and infestations | Systematic Assessment |
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| Culture-positive infections | Infections and infestations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John S. Gill | St Paul's Hospital | 604-806-8970 | jgill@providencehealth.bc.ca |
| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Black |
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| Asian |
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| Aboriginal |
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| Other |
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| Unknown |
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