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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: Completed Phase 4 study of BK Virus Infection, sponsored by The Methodist Hospital Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Ciprofloxacin
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
What the finished NCT01789203 record still lists
NCT01789203 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 47-participant average among 6 other BK Virus Infection trials with a reported enrollment target (326% higher).
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 a single indexed study location in 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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