Ciprofloxacin for Prevention of BK Infection

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Ciprofloxacin

Criteria

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