BK Treatment Study
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...
Brief Summary
Official Title: “Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: January 2012
Intervention(s) in this Clinical Trial
- Drug: levofloxacin
- 500 mg tablet, daily, 30 days
- Drug: placebo
- no dose, tablet, daily, 30 days
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Levofloxacin
- Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
- Placebo Comparator: placebo
- placebo identical to levofloxacin drug daily for 30 days
Outcome Measures for this Clinical Trial
Primary Measures
- decrease BK viremia
- Time Frame: 3 months after treatment completion
Safety Issue?: No
- Time Frame: 3 months after treatment completion
Secondary Measures
- decrease BK viremia
- Time Frame: 6 months after treatment
Safety Issue?: No
- Time Frame: 6 months after treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Brigham and Women's Hospital Other
Overall Clinical Trial Officials and Contacts
Anil Chandraker, MD Principal Investigator Brigham and Women's Hospital
Overall Contact: Anil Chandraker, MD 617-732-7412 achandraker@rics.bwh.harvard.edu
Related Publications
References
Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. Epub 2005 Jan 21.
Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01034176
Study ID Number: 2009p000020
ClinicalTrials.gov Identifier: NCT01034176
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01034176
