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BK Virus InfectionPhase 4NCT01789203

Ciprofloxacin for Prevention of BK Infection

A Phase 4 study testing Ciprofloxacin in people with BK Virus Infection, run by The Methodist Hospital Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
BK Virus Infection
What is being tested?
Ciprofloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited States
Study dates
Jan 2013to Oct 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Houston Methodist Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Ciprofloxacin, placebo
Keywords
BK infection, BK viremia, BK nephropathy, polyomavirus, fluoroquinolone, ciprofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiprofloxacinDrug

    Also called Cipro

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

  • placeboDrug

    Also called inactive drug, innocuous medication

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

Study groups in NCT01789203
Study groupRoleWhat they receive
CiprofloxacinActive comparatorCiprofloxacin will be administered as two-250 mg capsules, administered once daily for 3 months post-transplant
Receives: Drug: Ciprofloxacin
PlaceboPlacebo comparatorMatching placebo will be administered as two-capsules given once daily for 3 months post-transplant
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Developing BK Infection at 6 Months Post-transplant

    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.

    Measured: 6 months

Secondary outcomes (9)

  1. Number of Patients With Gram Negative Urinary Tract Infections at 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

    Measured: 6 months

  2. Number of Patients With Bacteremia at 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.

    Measured: 6 months

  3. Number of Patients With Quinolone-resistant Infection at 6 Months

    Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection

    Measured: 6 months

  4. Clostridium Difficile at 6 Months

    Clostridium difficile infection at 6 months

    Measured: 6 months

  5. Serious Adverse Events

    Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)

    Measured: 4 months

  6. Time to BK Infection

    Median time to initial BK viremia episode, days

    Measured: 12 months

  7. BK Viremia at 1 Year

    Proportion of patients developing BK viremia at 1 year

    Measured: 12 months

  8. First Plasma Viral Loads

    First BK plasma viral loads

    Measured: 12 months

  9. Acute Rejection at 1 Year

    Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789203
Sponsor's protocol ID
Pro00007510
Other IDs
IRB0612-0114
Status last verified
Oct 2019
First submitted
7 Feb 2013
Last updated
13 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, Torrence S, Schuessler R, Roby T, Gaudreault-Keener M, Storch GA. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction. Am J Transplant. 2005 Mar;5(3):582-94. doi: 10.1111/j.1600-6143.2005.00742.x.

    PubMed 15707414

  • Ali SH, Chandraker A, DeCaprio JA. Inhibition of Simian virus 40 large T antigen helicase activity by fluoroquinolones. Antivir Ther. 2007;12(1):1-6.

    PubMed 17503741

  • Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.

    PubMed 15712075

  • Miller AN, Glode A, Hogan KR, Schaub C, Kramer C, Stuart RK, Costa LJ. Efficacy and safety of ciprofloxacin for prophylaxis of polyomavirus BK virus-associated hemorrhagic cystitis in allogeneic hematopoietic stem cell transplantation recipients. Biol Blood Marrow Transplant. 2011 Aug;17(8):1176-81. doi: 10.1016/j.bbmt.2010.12.700. Epub 2010 Dec 23.

    PubMed 21185389

  • Gabardi S, Waikar SS, Martin S, Roberts K, Chen J, Borgi L, Sheashaa H, Dyer C, Malek SK, Tullius SG, Vadivel N, Grafals M, Abdi R, Najafian N, Milford E, Chandraker A. Evaluation of fluoroquinolones for the prevention of BK viremia after renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1298-304. doi: 10.2215/CJN.08261109. Epub 2010 May 27.

    PubMed 20507960

  • Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

    PubMed 39382091

  • Patel SJ, Knight RJ, Kuten SA, Graviss EA, Nguyen DT, Moore LW, Musick WL, Gaber AO. Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial. Am J Transplant. 2019 Jun;19(6):1831-1837. doi: 10.1111/ajt.15328. Epub 2019 Apr 4.

    PubMed 30811872

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofloxacin in people with BK Virus Infection, run by The Methodist Hospital Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Developing BK Infection at 6 Months Post-transplant (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789203, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.

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