Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial

Simple item page
dc.contributor.authorHumar, Atul
dc.contributor.authorGill, John
dc.contributor.authorJohnston, Olwyn
dc.contributor.authorFergusson, Dean
dc.contributor.authorHouse, Andrew A
dc.contributor.authorLebel, Louise
dc.contributor.authorCockfield, Sandra
dc.contributor.authorKim, S J
dc.contributor.authorZaltzman, Jeff
dc.contributor.authorCantarovich, Marcelo
dc.contributor.authorKarpinski, Martin
dc.contributor.authorRamsay, Tim
dc.contributor.authorKnoll, Greg A
dc.date.accessioned2013-06-25T15:03:46Z
dc.date.available2013-06-25T15:03:46Z
dc.date.issued2013-06-21
dc.date.updated2013-06-25T15:03:46Z
dc.description.abstractAbstract Background BK virus infection has emerged as a major complication in kidney 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. We 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. Methods/design 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. This is a multicenter, randomized, double-blind, placebo-controlled trial with two parallel arms conducted in 11 Canadian kidney transplant centers. A total of 154 patients with end-stage renal disease undergoing kidney transplantation will be randomized to receive a 3-month course of levofloxacin or placebo starting in the early post-transplant period. Levofloxacin will be administered at 500 mg po daily with dose adjustments based on kidney function. The primary outcome will be the time to occurrence of BK viruria within the first year post-transplantation. Secondary outcomes include BK viremia, measures of safety (adverse events, resistant infections,Clostridium difficile-associated diarrhea), measures of feasibility (proportion of transplanted patients recruited into the trial), proportion of patients adherent to the protocol, patient drop-out and loss to follow-up,and use of quinolone antibiotics outside of the trial protocol. Discussion Results from this pilot study will provide vital information to design and conduct a large, multicenter trial to determine if quinolone therapy decreases clinically meaningful outcomes in kidney transplantation. If levofloxacin significantly reduces BK viruria and urine viral loads in kidney transplantation, it will provide important justification to progress to the larger trial. If the full trial shows that levofloxacin significantly reduces BK infection and improves outcomes, its use in kidney transplantation will be strongly endorsed given the lack of proven therapies for this condition. Trial registration This trial was funded by the Canadian Institutes of Health Research (grant number:222493) and is registered at ClinicalTrials.gov ( NCT01353339).
dc.description.versionPeer Reviewed
dc.identifier.citationTrials. 2013 Jun 21;14(1):185
dc.identifier.doihttp://dx.doi.org/10.1186/1745-6215-14-185
dc.identifier.urihttp://hdl.handle.net/1993/21685
dc.language.rfc3066en
dc.rightsopen accessen_US
dc.rights.holderAtul Humar et al.; licensee BioMed Central Ltd.
dc.titleQuinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 2 of 2
Thumbnail Image
Name:
1745-6215-14-185.xml
Size:
54.65 KB
Format:
Extensible Markup Language
Description:
Download
Thumbnail Image
Name:
1745-6215-14-185.pdf
Size:
235.51 KB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.17 KB
Format:
Item-specific license agreed to upon submission
Description:
Download
Collections
University of Manitoba Scholarship
Rady Faculty of Health Sciences Scholarly Works