Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection

• Status: Completed
• Trial end date: 2016-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Calcium heparin; Ethanol; Heparin

Criteria

Inclusion Criteria:

• Subjects ≥6 months to < 25 years of age who are ≥5kg

• New diagnosis (within 96 hours of collection of first positive blood culture) of CLABSI (participants with previous CLABSI will be eligible if not previously enrolled in the study)

• Silicone CVAD in situ (ports, Hickman and Broviac lines will all be eligible)

• Treating clinician plans to attempt salvage of CVAD

• Participant is receiving treatment for cancer or any hematologic disorder or is receiving hematopoietic stem cell transplantation (HSCT) at a participating institution.

Exclusion Criteria:

• Allergy to ethanol or components of placebo lock

• Concomitant use of metronidazole, disulfiram or trabectedin

• Plan to remove CVAD within 6 days

• Continuous use of all lumens of CVAD leading to anticipated inability to lock each lumen for at least 2 hours per day

• Known CVAD obstruction

• Subjects who are capable of becoming pregnant will require an negative pregnancy test before entry to study

• Use of ELT in the preceding 2 weeks

• Expected survival <6 days

• Proven alternative source of bloodstream infection (BSI), or clinical evidence of CVAD track or port-pocket infection

• Multiple long-term CVADs in situ