Ciprofloxacin for Prevention of BK Infection

Completed · Phase 4 · Has a placebo group

Conditions studied: BK Virus Infection

In brief

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.

Key facts

Study ID

NCT01789203

Run by

The Methodist Hospital Research Institute

People needed

200

Starts

2013-01-01

Expected to finish

2017-10-01

Last updated by the study team

2019-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.