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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive
      blood culture and randomized to blinded treatment with 70% ethanol or heparin-saline placebo
      catheter lock therapy.

      After enrollment, all subjects will receive catheter lock therapy for a 5 day Treatment
      Phase, followed by a 24 week Prophylaxis Phase. Participants in the active treatment arm will
      receive 70% ethanol locks and those in the placebo arm will receive heparin-saline placebo
      locks in identical fashion.

      In addition to the study intervention, participants in both arms will receive standard
      systemic antibiotic therapy according to the preference of the ward clinician.

      The intervention will continue for 24 weeks unless off-therapy criteria are met or the
      catheter is removed.

      After the intervention is discontinued, participants will be monitored for 90 days, or 30
      days after line removal, whichever is shorter. If the intervention is discontinued prior to
      24 weeks due to adverse event or physician request, participants will be monitored for the
      remainder of the 24 week period.

      Primary Objective:

        -  To compare the proportion of therapeutic failures in children and adolescents with
           CLABSI during treatment with standard care plus Ethanol Lock Therapy (ELT) versus
           standard care alone.

      Secondary Objectives:

        -  To estimate and compare the cumulative incidence of CLABSI treatment failure, relapse or
           reinfection in children and adolescents receiving ELT plus standard care versus those
           receiving standard care alone.

        -  To estimate the risk of central venous access device (CVAD) occlusion associated with
           the use of ELT plus standard care, compared with standard care alone, in children and
           adolescents.

        -  To estimate the risk of adverse events possibly attributable to ELT associated with the
           use of ELT plus standard care, compared with standard care alone, in children and
           adolescents.
    

Intervention name(s): ethanol; heparin-saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): 70% ethanol catheter lock therapy; heparin-saline placebo catheter lock therapy
Other intervention name(s): 70% ethanol; heparin-saline
Intervention MeSH terms: Ethanol; Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: central line; adolescents; children; bloodstream infection; antibiotic lock therapy; catheter lock therapy; ethanol lock therapy