Status:
COMPLETED
A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
Lead Sponsor:
University of California, San Diego
Conditions:
End-Stage Renal Disease
Hemodialysis Catheter-associated Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated cathete...
Eligibility Criteria
Inclusion
- Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.
Exclusion
- Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00614679
Start Date
October 1 2006
End Date
December 1 2009
Last Update
October 9 2019
Active Locations (3)
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1
Ben Taub General Hospital
Houston, Texas, United States, 77030
2
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
3
The Methodist Hospital
Houston, Texas, United States, 77030