BK Virus Infection Clinical Trial
Official title:
Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients
Verified date | October 2019 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BK infection is an important cause of 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 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. Some data, however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against BK virus. This has led us to investigate whether routine, short-term ciprofloxacin administration post-transplant can lower the incidence of BK infection.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female subjects over the age of 18 years - Recipients of a primary or repeat renal allograft either alone (from a deceased or living donor) or as a dual-kidney transplant - Signed informed consent form prior to any research assessment Exclusion Criteria: - Patients with known severe allergy to ciprofloxacin - History of tendon rupture or tendinitis - Use of antiarrythmic drugs known to prolong the QT interval such as class IA antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmic drugs (e.g. amiodarone, sotalol) - Patients with history of previous non-renal transplantation - Recipients administered rituximab within one year prior to transplantation, or recipients expected to receive rituximab as part of desensitization strategy or for the presence of historical donor specific antibodies - QTc interval interval of greater than 500 msec on admission or post-operative EKG - BK nephropathy with previous transplant - BK viremia on admission - Any condition present during the initial transplant hospitalization that in the investigator's judgment would increase the risk associated with participation in the study |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Methodist Hospital System |
United States,
Ali SH, Chandraker A, DeCaprio JA. Inhibition of Simian virus 40 large T antigen helicase activity by fluoroquinolones. Antivir Ther. 2007;12(1):1-6. — View Citation
Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, Torrence S, Schuessler R, Roby T, Gaudreault-Keener M, Storch GA. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94. Erratum in: Am J Transplant. 2005 Apr;5(4 Pt 1):839. — View Citation
Gabardi S, Waikar SS, Martin S, Roberts K, Chen J, Borgi L, Sheashaa H, Dyer C, Malek SK, Tullius SG, Vadivel N, Grafals M, Abdi R, Najafian N, Milford E, Chandraker A. Evaluation of fluoroquinolones for the prevention of BK viremia after renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1298-304. doi: 10.2215/CJN.08261109. Epub 2010 May 27. — View Citation
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
Miller AN, Glode A, Hogan KR, Schaub C, Kramer C, Stuart RK, Costa LJ. Efficacy and safety of ciprofloxacin for prophylaxis of polyomavirus BK virus-associated hemorrhagic cystitis in allogeneic hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2011 Aug;17(8):1176-81. doi: 10.1016/j.bbmt.2010.12.700. Epub 2010 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Graft Loss at 1 Year | kidney failure within first 1 year of transplant | 12 months | |
Other | Death at 1 Year | Patient death at 1 year | 12 months | |
Primary | Number of Patients Developing BK Infection at 6 Months Post-transplant | Number of patients (followed by proportion) 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. | 6 months | |
Secondary | Number of Patients With Gram Negative Urinary Tract Infections at 6 Months | Number of patients with gram negative urinary tract infections as defined by a midstream urine sample containing 10^4 or more colony-forming units per mL | 6 months | |
Secondary | Number of Patients With Bacteremia at 6 Months | Number of patients with bacteremic infection at 6 months. Bacteremia defined by a single positive blood culture that was not thought to be contaminated. | 6 months | |
Secondary | Number of Patients With Quinolone-resistant Infection at 6 Months | Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection | 6 months | |
Secondary | Clostridium Difficile at 6 Months | Clostridium difficile infection at 6 months | 6 months | |
Secondary | Serious Adverse Events | Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month) | 4 months | |
Secondary | Time to BK Infection | Median time to initial BK viremia episode, days | 12 months | |
Secondary | BK Viremia at 1 Year | Proportion of patients developing BK viremia at 1 year | 12 months | |
Secondary | First Plasma Viral Loads | First BK plasma viral loads | 12 months | |
Secondary | Acute Rejection at 1 Year | Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification | 12 months |
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