Ciprofloxacin for Prevention of BK Infection
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|ClinicalTrials.gov Identifier: NCT01789203|
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|BK Virus Infection||Drug: Ciprofloxacin Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||October 2017|
Active Comparator: Ciprofloxacin
Ciprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant
Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.
Other Name: Cipro
Placebo Comparator: Placebo
Matching placebo will be administered as two-capsules given once daily for 3 months post-transplant
Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.
- Number of Patients Developing BK Infection at 6 Months Post-transplant [ Time Frame: 6 months ]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.
- Number of Patients With Gram Negative Urinary Tract Infections at 6 Months [ Time Frame: 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
- Number of Patients With Bacteremia at 6 Months [ Time Frame: 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.
- Number of Patients With Quinolone-resistant Infection at 6 Months [ Time Frame: 6 months ]Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection
- Clostridium Difficile at 6 Months [ Time Frame: 6 months ]Clostridium difficile infection at 6 months
- Serious Adverse Events [ Time Frame: 4 months ]Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)
- Time to BK Infection [ Time Frame: 12 months ]Median time to initial BK viremia episode, days
- BK Viremia at 1 Year [ Time Frame: 12 months ]Proportion of patients developing BK viremia at 1 year
- First Plasma Viral Loads [ Time Frame: 12 months ]First BK plasma viral loads
- Acute Rejection at 1 Year [ Time Frame: 12 months ]Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification
- Graft Loss at 1 Year [ Time Frame: 12 months ]kidney failure within first 1 year of transplant
- Death at 1 Year [ Time Frame: 12 months ]Patient death at 1 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789203
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||Samir J Patel, Pharm.D.||Clinical Pharmacist|
|Principal Investigator:||Ahmed O Gaber, MD||Director, Houston Methodist Transplant Center|