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NCT01789203 · ClinicalTrials.gov registry record · Phase 4

Ciprofloxacin for Prevention of BK Infection

A Phase 4 study of BK Virus Infection, sponsored by The Methodist Hospital Research Institute.

Completed
Registry status
Phase 4
Development phase
200
Enrollment target
1
Study location

NCT01789203 is a Phase 4 study of BK Virus Infection that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 200 participants, above the 47-participant average among 6 other BK Virus Infection trials with a reported enrollment target (326% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT01789203, a Phase 4 study of BK Virus Infection, has completed, sponsored by The Methodist Hospital Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
200 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG placebo
  • DRUG Ciprofloxacin

Study Locations (1)

Texas

  • Houston Methodist Hospital - Houston

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2013-01
Est. Completion 2017-10
Phase Phase 4

What the Registry Record Tells You About NCT01789203

The ClinicalTrials.gov registry entry for NCT01789203 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 47-participant average among 6 other BK Virus Infection trials with a reported enrollment target (326% higher). The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with BK Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01789203 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01789203 about?

NCT01789203 is a clinical study titled "Ciprofloxacin for Prevention of BK Infection". 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...

What is the current status of trial NCT01789203?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2013-01. Estimated completion is 2017-10.

What conditions does trial NCT01789203 study?

This clinical trial studies the following conditions: BK Virus Infection.

What interventions are being tested in trial NCT01789203?

The interventions under investigation include: placebo (DRUG), Ciprofloxacin (DRUG).

Who is sponsoring clinical trial NCT01789203?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01789203 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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