Phase 4
Completed N=43
BK Treatment Study
BK Viremia
Source: ClinicalTrials.gov NCT01034176 ↗
Enrolled (actual)
43
Serious AEs
5.1%
Results posted
Mar 2017
Primary outcomePrimary: Percent Change From Baseline in BK Virus Copies at 3 Months — 70.3; 69.1 Percent change of BK virus copies
◆ Published Evidence
Established
94citations · ~8 / year
Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.
Summary
Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.
Linked Publications (2)
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Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.
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Interventions for BK virus infection in kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in BK Virus Copies at 3 Months |
70.3; 69.1 | — |
| SECONDARY Number of Patients With >50% Reduction in BK Virus Copies |
15; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia
Exclusion Criteria
- Female patients of childbearing age who are pregnant or in whom adequate contraception cannot be maintained.
- Patients with active infections, history of malignancy/Posttransplant Lymphoproliferative Disease (PTLD) serologic positivity to HIV.
- Patients with evidence of urinary tract obstruction causing allograft dysfunction, unless corrected by time of enrollment.
- Patients with clinical or morphological evidence of recurrence of primary disease.
- Patients with a history of allergic reaction to quinolone antibiotics.
- Patients with history of prolong QT interval
- Patients with recurrent hypoglycemic episodes
- Patients with history of myasthenia gravis
- Patients taking Thioridazine
Data sourced from ClinicalTrials.gov (NCT01034176) and the linked publication. 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. Informational only — not medical advice.