Non-Therapeutic Protocol

ETHEL: 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

Type of Protocol/Clinical Study

Associated Infectious Diseases Studies : Central line associated bloodstream infection (CLABSI)

Description

Central lines and ports increase the chance of getting a bloodstream infection from bacteria or fungus attaching to the line, called a line infection. Line infections generally require hospital admission and antibiotics. Antibiotics usually help 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 much higher. This study will look to see if using ethanol lock therapy (ELT) will improve the chance of curing a line infection and prevent another one. ELT is done by injecting a mixture of ethanol and water into the line or port for 2 hours and then removing it.

Objectives

• To determine the efficacy of standard care plus ethanol lock therapy (ELT) as a treatment and as preventative for central line associated bloodstream infection, compared with standard treatment alone, in children and adolescents.

Eligibility Criteria

• Participant is ≥ 6 months and < 25 years of age and is ≥ 5 kg.
• Participant has new diagnosis of central line associated blood stream infection with a silicone catheter (ports, and Broviac or Hickman lines will be eligible).
• Participant has not received ELT in the preceding 2 weeks.
• Participant does not have multiple long-term central lines.
• Participant is not pregnant prior to study entry.
• The treating clinician plans to salvage the line.
• Participant is expected to survive at least 6 days.
• Participant is not allergic to ethanol or taking any medications which are contraindicated.
• Participant is receiving treatment for any disease at St Jude.

Principal Investigator

Joshua Wolf, MD

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