Phase 4
N=154
Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
Disease Due to BK Polyomavirus · Kidney Transplant Infection
Bottom Line
View on ClinicalTrials.gov: NCT01353339 ↗Enrolled (actual)
154
Serious AEs
4.6%
Results posted
Apr 2024
Primary outcome: Primary: Occurrence of BK Viruria — 22; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levofloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of BK Viruria |
22; 26 | — |
| SECONDARY Adverse Events |
27; 29 | — |
| SECONDARY Acute Rejection |
6; 5 | — |
| SECONDARY Clostridium Difficile Associated Diarrhea |
36; 30 | — |
| SECONDARY Infections |
1.4; 1.3 | — |
| SECONDARY Quinolone Resistance |
14; 15 | — |
| SECONDARY Allograft Loss |
0; 1 | — |
| SECONDARY Mortality |
0; 0 | — |
| SECONDARY Adherence |
68.5; 70.4 | — |
| SECONDARY Use of Quinolones |
19; 14 | — |
| SECONDARY Proportion of Patient Drop-out and Loss to Follow-up |
0; 0 | — |
| SECONDARY Quantitative BK Urine Viral Load |
7550; 4503 | — |
| SECONDARY BK Viremia |
6; 9 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01353339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.