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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: Completed Phase 3 study, sponsored by St. Jude Children's Research Hospital.
NCT01472965 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 95 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.
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 |
What the finished NCT01472965 record still lists
NCT01472965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which ethanol is the first listed.
NCT01472965 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01472965's enrollment target sits among peer trials
95 1719th of 2000 higher than 282 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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