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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levofloxacin | Active Comparator | Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days |
|
| placebo | Placebo Comparator | placebo identical to levofloxacin drug daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levofloxacin | Drug | 500 mg tablet, daily, 30 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in BK Virus Copies at 3 Months | Percent change in BK virus copies/mL from Baseline to 3 months | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With >50% Reduction in BK Virus Copies | Number of patients with >50% reduction in BK viral load at 6 months | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Chandraker, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15712075 | Background | 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. doi: 10.1086/427291. Epub 2005 Jan 21. | |
| 16206122 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levofloxacin | Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days |
| FG001 | Placebo | placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levofloxacin | Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days |
| BG001 | Placebo | placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in BK Virus Copies at 3 Months | Percent change in BK virus copies/mL from Baseline to 3 months | Posted | Median | Standard Deviation | Percent change of BK virus copies | Baseline and 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levofloxacin | Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days levofloxacin: 500 mg tablet, daily, 30 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neoplasm, malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | unrelated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| achilles tendon strain/injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | possibly related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anil Chandraker | Brigham and Women's Hospital | 617-525-8203 | achandraker@partners.org |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| placebo | Drug | no dose, tablet, daily, 30 days |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Fletcher Allen Health Care/University of Vermont | Burlington | Vermont | 05401 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| Randhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. doi: 10.1086/497080. No abstract available. |
| 39382091 | Derived | Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2. |
| 24482066 | Derived | Lee BT, Gabardi S, Grafals M, Hofmann RM, Akalin E, Aljanabi A, Mandelbrot DA, Adey DB, Heher E, Fan PY, Conte S, Dyer-Ward C, Chandraker A. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. Clin J Am Soc Nephrol. 2014 Mar;9(3):583-9. doi: 10.2215/CJN.04230413. Epub 2014 Jan 30. |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Patients With >50% Reduction in BK Virus Copies | Number of patients with >50% reduction in BK viral load at 6 months | number of patients with >50% reduction in BK viral load at 6 months | Posted | Number | participants | Baseline and 6 months |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 2 |
| 20 |
| EG001 | Placebo | placebo identical to levofloxacin drug daily for 30 days placebo: no dose, tablet, daily, 30 days | 1 | 19 | 1 | 19 | 0 | 19 |
|
| suicidal ideation | Psychiatric disorders | Systematic Assessment | unrelated |
|
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |