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NCT01472965 · ClinicalTrials.gov registry record · Phase 3
Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
NCT01472965 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 95 participants.
The verdict
NCT01472965, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
Study Summary
Use of long-term central venous access devices (including tunneled lines and ports) can be associated with development of bloodstream infection caused by build-up of bacteria or fungus on the inside of the device, called central line associated bloodstream infection (CLABSI). This infection generally requires hospital admission and antibiotic therapy. This treatment usually helps eradicate the infection but sometimes it is not possible to clear or it comes back after treatment. Also, once someone has had one line infection the chance of getting another one is higher. This study will test whether treatment and secondary prophylaxis of CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse or reinfection) in children and adolescents treated for cancer or hematologic disorders or undergoing hematopoietic stem cell transplantation (HSCT). ELT involves injecting a solution of ethanol and water into the line or port, allowing it to dwell for 2 hours, and then withdrawing the solution.
Interventions
- DRUG ethanol
- DRUG heparin-saline placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2011-12-29 |
| Est. Completion | 2016-11-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01472965
The ClinicalTrials.gov registry entry for NCT01472965 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ethanol is the first listed.
NCT01472965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01472965 about?
NCT01472965 is a clinical study titled "Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection". Use of long-term central venous access devices (including tunneled lines and ports) can be associated with development of bloodstream infection caused by build-up of bacteria or fungus on the inside of the device, called central line associated bloodstream infection (CLABSI). This infection generall...
What is the current status of trial NCT01472965?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2011-12-29. Estimated completion is 2016-11-11.
What interventions are being tested in trial NCT01472965?
The interventions under investigation include: ethanol (DRUG), heparin-saline placebo (DRUG).
Who is sponsoring clinical trial NCT01472965?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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