CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Ciprofloxacin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01789203
NCT01789203Phase 4Completed

Ciprofloxacin for Prevention of BK Infection in Renal Transplant Recipients

The Methodist Hospital Research Institute·interventional·Posted Feb 12, 2013·Updated Nov 13, 2019

In Brief

A Phase 4 clinical trial evaluating Ciprofloxacin and placebo for BK Virus Infection. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 12, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.4 years ago

Interventions

Ciprofloxacindrug

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

placebodrug

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