Overview

This trial is active, not recruiting.

Condition central line-associated bloodstream infection
Treatments ethanol, heparin-saline placebo
Phase phase 3
Sponsor St. Jude Children's Research Hospital
Start date December 2011
End date February 2017
Trial size 95 participants
Trial identifier NCT01472965, ETHEL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol 70% ethanol
70% ethanol catheter lock therapy
(Placebo Comparator)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo heparin-saline
heparin-saline placebo catheter lock therapy

Primary Outcomes

Measure
Proportion of therapeutic failures (early or late failure) in children and adolescents with CLABSI receiving standard care plus ELT
time frame: Up to 25 weeks after the start of treatment.
Proportion of therapeutic failures (early or late failure) in children and adolescents with CLABSI receiving standard care alone
time frame: Up to 25 weeks after the start of treatment

Secondary Outcomes

Measure
Cumulative incidence of therapeutic failure in participants receiving standard care plus ELT
time frame: Up to 37.5 weeks after the start of treatment
Cumulative incidence of therapeutic failure in participants receiving standard care alone
time frame: Up to 37.5 weeks after the start of treatment
Cumulative incidence of relapse in participants receiving standard care plus ELT
time frame: Up to 37.5 weeks after the start of treatment
Cumulative incidence of relapse in participants receiving standard care alone
time frame: Up to 37.5 weeks after the start of treatment.
Cumulative incidence of reinfection in participants receiving standard care plus ELT
time frame: Up to 37.5 weeks after the start of treatment.
Cumulative incidence of reinfection in participants receiving standard care alone
time frame: Up to 37.5 weeks after the start of treatment.
Rate of CVAD occlusion events in participants receiving standard care plus ELT
time frame: Up to 37.5 weeks after the start of treatment.
Rate of CVAD occlusion events in participants receiving standard care alone
time frame: Up to 37.5 weeks after the start of treatment.
Adverse events in participants receiving standard care plus ELT
time frame: Up to 37.5 weeks after the start of treatment.
Adverse events in participants in participants receiving standard care alone
time frame: Up to 37.5 weeks after the start of treatment.

Eligibility Criteria

Male or female participants from 6 months up to 25 years old.

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

Additional Information

Official title 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
Principal investigator Joshua Wolf, MBBS, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by St. Jude Children's Research Hospital.