At a glance
ClinicalIndex Comparison Record- ✓Age 6 months to <25 years and weight ≥5 kg
- ✓New diagnosis of CLABSI within 96 hours of first positive blood culture; prior CLABSI permitted if not previously enrolled
- ✓Silicone central venous access device in place (ports, Hickman, or Broviac lines)
- ✓Clinician plans to attempt salvage of the CVAD
- ✕Allergy to ethanol or placebo lock components
- ✕Concomitant use of metronidazole, disulfiram, or trabectedin
- ✕Plan to remove CVAD within 6 days
- ✕All lumens of CVAD in continuous use preventing ≥2 hours daily lock per lumen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled, Trial of Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children and Adolescents
In Brief
A Phase 3 clinical trial evaluating ethanol and heparin-saline placebo for Central Line-Associated Bloodstream Infection. Completed, enrolled 95 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
70% ethanol catheter lock therapy
heparin-saline placebo catheter lock therapy