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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Masking: Open Label


Related Conditions & MeSH terms

  • Bacteremia
  • Hemodialysis Catheter-related Bacteremia

NCT number NCT02040818
Study type Interventional
Source University of California, San Diego
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date November 2013