Status:
UNKNOWN
Ethanol Lock for the Salvage of Infected Long-term Vascular Access
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Bacteremia
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this st...
Eligibility Criteria
Inclusion
- Age: \>1 year and 10 Kgs
- Long-term vascular device in place at least for 7 days
- Catheter-related infection (at least presumed)
- Will to save the infected device (expected high risk access)
Exclusion
- Known ethanol-allergy
- Known antabuse-like drugs in use
- Religious refusal
- S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
- Tract or pocket infection
- Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01186172
Start Date
June 1 2010
End Date
June 1 2013
Last Update
January 5 2012
Active Locations (1)
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1
Fondazione IRCCS Policlinico "San Matteo"
Pavia, PV, Italy, 27100