BK Treatment Study

BK Viremia Clinical Trial

Official title:

Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034176
• Other study ID #: 2009p000020
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2009
• Last updated: October 9, 2012
• Start date: February 2009
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• BK Viremia
• Viremia

Intervention

Drug:
• levofloxacin
500 mg tablet, daily, 30 days
• placebo
no dose, tablet, daily, 30 days

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Fletcher Allen Health Care/University of Vermont	Burlington	Vermont
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease BK viremia		3 months after treatment completion	No
Secondary	decrease BK viremia		6 months after treatment	No