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Ciprofloxacin for Prevention of BK Infection

NCT01789203 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-11-13

Study results available
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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. 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.

Conditions

  • BK Virus Infection

Interventions

DRUG

Ciprofloxacin

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

DRUG

placebo

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

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Samir J Patel, Pharm.D. · Clinical Pharmacist

  • Ahmed O Gaber, MD · Director, Houston Methodist Transplant Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-04-30
Completion
2017-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789203 on ClinicalTrials.gov