Status:
COMPLETED
Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Central Line-Associated Bloodstream Infection
Eligibility:
All Genders
6-25 years
Phase:
PHASE3
Brief 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 o...
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2016
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01472965
Start Date
December 29 2011
End Date
November 11 2016
Last Update
November 13 2017
Active Locations (2)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
2
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052