Ciprofloxacin for Prevention of BK Infection

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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BK Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ciprofloxacin

Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.

Placebo

Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.

Interventions

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Ciprofloxacin

Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.

Intervention Type DRUG

placebo

Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.

Intervention Type DRUG

Other Intervention Names

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Cipro inactive drug innocuous medication

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No