Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
Condition: Central Line-Associated Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Intervention: ethanol; heparin-saline placebo
Intervention description: 70% ethanol catheter lock therapy; heparin-saline placebo catheter lock therapy
Intervention MeSH terms: Ethanol; Heparin; Calcium heparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 6 Months
Maximum age: 25 Years
Healthy volunteers: No
Keywords: central line; adolescents; children; bloodstream infection; antibiotic lock therapy; catheter lock therapy; ethanol lock therapy

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.
    

Eligibility 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