A Phase 3 interventional study of Ethanol-lock therapy and Antibiotic-lock in Bacteremia, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Status unknown at 1 site in Italy. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2012-01-05.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Phase 3, Interventional, and Treatment
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.
322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.
This study's planned enrollment of 200 is above the median of 149 across 171 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with a combination of ethanol-lock and parenteral therapy
Drug: Ethanol-lock therapy
Treatment with a combination of antibiotic-lock and parenteral therapy
Drug: Antibiotic-lock
Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
Ratio of saved devices
Time frame: 7 days
Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability
Major adverse event (stop protocol): anaphylaxis, antabuse-like reaction, device damage, severe dysphoric reaction. Minor adverse events (do not stop protocol): nausea, vomiting, headache, dizziness.
Time frame: 60 days
Number of patients with proper parenteral therapy
Verified by an Infectious Diseases Specialist
Time frame: 7 days
Ratio of saved devices
Time frame: 15-30-60 days
Time for next bacteriemic episode
Time frame: 30 days after the end of lock
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia