BK Virus Infection Clinical Trial
Official title:
Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients
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.
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.
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