Ciprofloxacin for Prevention of BK Infection
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|ClinicalTrials.gov Identifier: NCT01789203|
Recruitment Status : Unknown
Verified March 2016 by Samir J. Patel, The Methodist Hospital System.
Recruitment status was: Recruiting
First Posted : February 12, 2013
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|BK Virus Infection||Drug: Ciprofloxacin Drug: placebo||Phase 4|
BK virus is a member of the virus family polyomaviridae ("polyoma"). The virus, which can manifest as a viral nephritis, was first described in a renal transplant recipient in 1971, however it was not until the past decade that infection with BK virus became known as an important contributor to graft dysfunction and graft loss after renal transplantation. It has been widely accepted that emergence of BK virus correlates with the more potent immunosuppressive agents currently used to lower acute rejection rates. In contrast to other opportunistic infections after transplantation, for which routine prophylactic agents are administered, there is no effective agent for the prevention of BK infection, nor is there an effective agent for treating BK infection once it occurs.
Ciprofloxacin is a well known anti-infective agent in the fluoroquinolone class of antibiotics. It is most active against gram-negative enteric pathogens, and is commonly used for a variety of infectious indications.
Though classified as antibacterial agents, fluoroquinolones have been suggested to exhibit anti-BK viral effects by interfering with helicase activity of the BK virus large T antigen. Ciprofloxacin has been shown in previous studies to reduce urine BK viral load, and BK-associated hemorrhagic cystitis in the stem cell transplant population. Ciprofloxacin has also been associated with a lower incidence of BK viremia in one retrospective study in kidney transplant recipients. Based on these reports, the investigators hope to find a reduction BK viremia and BK nephropathy using a prospective, randomized study design.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Active Comparator: Ciprofloxacin
Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant
Patients will be randomized 2:1 active comparator to placebo comparator.
Other Name: Cipro
Placebo Comparator: Placebo
Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant
- BK infection at 6 months post-transplant [ Time Frame: 6 months ]Proportion of patients developing BK infection at 6 months post-transplant. BK infection is defined as the presence of a detectable BK viral load in plasma by polymerase chain reaction (PCR), or the presence of BK viral inclusions on kidney biopsy specimens.
- Incidence of urinary tract infections as defined by a midstream urine sample containing 10^4 or more colony-forming units per mL [ Time Frame: 6 months ]
- Incidence of bacteremic infections at 6 months. Incidence of bacteremia as defined by a single positive blood culture that was not thought to be contaminated. [ Time Frame: 6 months ]
- Incidence of quinolone-resistant bacterial infections [ Time Frame: 6 months ]
- Incidence of clostridium difficile infection [ Time Frame: 6 months ]
- Serious adverse events [ Time Frame: 6 months ]
- Time to BK infection [ Time Frame: 12 months ]
- Proportion of patients developing BK infection at 1 year [ Time Frame: 12 months ]
- First and peak plasma viral loads [ Time Frame: 12 months ]
- Incidence of acute rejection at 1 year [ Time Frame: 12 months ]
- Incidence and severity of BK nephropathy, as defined by positive staining of histopathological specimen, at 1 year [ Time Frame: 12 months ]
- Dose discontinuation due to adverse event related to therapy [ Time Frame: 3 months ]
- Serum creatinine concentrations at 1, 3, 6, 9, and 12 months post-transplant [ Time Frame: 12 months ]
- Graft loss at 1 year [ Time Frame: 12 months ]
- Death at 1 year [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789203
|Contact: Samir J Patel, Pharm.D.||firstname.lastname@example.org|
|Contact: Joy V Nolte, MPH, RD, LDemail@example.com|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Joy V Nolte, MPH, RD, LD 713-441-6314 firstname.lastname@example.org|
|Sub-Investigator: A. Osama Gaber, MD|
|Sub-Investigator: Richard J Knight, MD|
|Sub-Investigator: Hemangshu Podder, MD|
|Sub-Investigator: Stacy Crow, Pharm.D.|
|Principal Investigator: Samir J Patel, Pharm.D.|
|Sub-Investigator: Samantha Kuten, Pharm.D.|
|Sub-Investigator: Jill Krisl, Pharm.D.|
|Principal Investigator:||Samir J Patel, Pharm.D.||Clinical Pharmacist|