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NCT02095951 · ClinicalTrials.gov registry record · Phase 4
Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
A Phase 4 study, sponsored by Children's Hospital of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02095951 is a Phase 4 study that has completed, run by Children's Hospital of Michigan. The registered enrollment target is 30 participants.
The verdict
NCT02095951, a Phase 4 study, has completed, sponsored by Children's Hospital of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters. Participants will be enrolled from patients with hematologic/oncologic disorders and bone marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be defined as the number of hospital days between first symptoms of Catheter-related infection (CRI) (or date of admission for those admitted with symptoms) and first negative blood culture. Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics, for the treatment of CRI (suspected or proven) of the blood in children with central catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and attributable LOS (ALOS) and therefore lower hospital costs.
Interventions
- DRUG Ethanol lock therapy (ELT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02095951
The ClinicalTrials.gov registry entry for NCT02095951 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Michigan, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ethanol lock therapy (ELT) is the first listed.
NCT02095951 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02095951 about?
NCT02095951 is a clinical study titled "Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection". The study team will compare hospital length of stay (LOS) and attributable length of stay (ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for up to 72 hours) placed w...
What is the current status of trial NCT02095951?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2014-06. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02095951?
The interventions under investigation include: Ethanol lock therapy (ELT) (DRUG).
Who is sponsoring clinical trial NCT02095951?
This trial is sponsored by Children's Hospital of Michigan, which has 5 total clinical trials registered on ClinicalTrials.gov.
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