drugset / Trial / NCT01353339
Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
Phase 4
Completed
154 enrolled
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR) · collabDalhousie University · collabLondon Health Sciences Centre · collabMcGill University Health Centre/Research Institute of the McGill University Health Centre · collabSt. Joseph's Healthcare Hamilton · collabSt. Paul's Hospital, Canada · collabUnity Health Toronto · collabUniversity Health Network, Toronto · collabUniversity of Alberta · collabUniversity of Manitoba · collabVancouver General Hospital · collab
RandomizedParallel-groupQuadruple-blindPrevention
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
Timeline
- Start
- 2011-12-01
- Primary completion
- 2014-02-25
- Completion
- 2014-02-25
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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levofloxacin | Small molecule | 500 mg | Oral |