Treatment of Hemodialysis Catheter-Related Bacteremia
Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream infections that arise from the catheter. There are several management options for treatment of such an infection, though the best option is not clearly delineated. Standard of care options include exchanging the catheter for a new one over a guide-wire and instilling a high concentration of an antibiotic directly into the catheter lumen. The investigators are planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1. Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new one. Both these options have comparable cure rates as shown in the medical literature. After obtaining informed consent, patients will be randomized to either treatment arm and will continue to receive all other standard medical care.
Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related bacteremia.
|Hemodialysis Catheter-related Bacteremia||Drug: tigecycline, N-acetylcysteine, heparin combination Device: guide-wire exchange||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Masking: Open Label
|Official Title:||RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia|
- Treatment Success [ Time Frame: 28 days ]The primary outcome is successful treatment of infection defined as clinical and microbiologic resolution of the initial bacteremia with absence of persistent or recurrent catheter-related bacteremia at day 28 (one week after end of treatment).
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
|Experimental: Antibiotic Lock Solution||Drug: tigecycline, N-acetylcysteine, heparin combination|
|Active Comparator: Guide-wire Exchange||Device: guide-wire exchange|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040818
|United States, California|
|University of California, San Diego Medical Center|
|San Diego, California, United States, 92103|