BK Treatment Study
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: BK Viremia
Intervention: levofloxacin (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
Anil Chandraker, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
Anil Chandraker, MD, Phone: 617-732-7412, Email: achandraker@rics.bwh.harvard.edu
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.
Clinical Details
Official title: Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: decrease BK viremia
Secondary outcome: decrease BK viremia
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Anil Chandraker, MD, Phone: 617-732-7412, Email: achandraker@rics.bwh.harvard.edu
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Anil Chandraker, MD, Principal Investigator
Steve Gabardi, PharmD, Sub-Investigator
Nader Najafian, MD, Sub-Investigator
Edgar Milford, MD, Sub-Investigator
Reza Abdi, MD, Sub-Investigator
Nidyanandh Vadivel, MD, Sub-Investigator
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Didier Manddelbrot, MD, Phone: 617-632-9700, Email: dmandelb@bidmc.harvard.edu
Didier Mandelbrot, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Eliot Heher, MD, Phone: 617-726-5050, Email: eheher@partners.org
Eliot Heher, MD, Principal Investigator
Lahey Clinic Medical Center, Burlington, Massachusetts 01805, United States; Recruiting
Monica Grafals, MD, Phone: 781-744-2500, Email: Monica.grafals@lahey.org
Monica Grafals, MD, Principal Investigator
UMASS Memorial Medical Center, Worcester, Massachusetts 01655, United States; Recruiting
Pang-Yen Fan, MD, Phone: 774-443-2052, Email: Pang-yen.Fan@umassmemorial.org
Pang-yen Fan, MD, Principal Investigator
Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Enver Akalin, MD, Phone: 718-920-4815, Email: eakalin@montefiore.org
Enver Akalin, MD, Principal Investigator
Fletcher Allen Health Care/University of Vermont, Burlington, Vermont 05401, United States; Recruiting
Deborah Adey, MD, Phone: 802-847-4774, Email: Deborah.adey@vtmednet.org
Deborah Adey, MD, Principal Investigator
University of Wisconsin Hospital, Madison, Wisconsin 53792, United States; Recruiting
R.Michael Hofmann, MD, Phone: 608-270-5687, Email: rmh@medicine.wisc.edu
R. Michael Hofmann, MD, Principal Investigator
Additional Information
Related publications: 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.
Starting date: February 2009
Last updated: November 7, 2011
|
