Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Ratio of saved devices
Study Overview
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 study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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)
Arms & Interventions
Ethanol-lock
Treatment with a combination of ethanol-lock and parenteral therapy
Intervention: Ethanol-lock therapy (Drug)
Antibiotic lock
Treatment with a combination of antibiotic-lock and parenteral therapy
Intervention: Antibiotic-lock (Drug)
Outcomes
Primary Outcomes
Ratio of saved devices
Time Frame: 7 days
Secondary Outcomes
- Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability(60 days)
- Number of patients with proper parenteral therapy(7 days)
- Ratio of saved devices(15-30-60 days)
- Time for next bacteriemic episode(30 days after the end of lock)
Investigators
Michele Pagani
Dirigente Medico 1 livello
Fondazione IRCCS Policlinico San Matteo di Pavia