Treatment of Hemodialysis Catheter-Related Bacteremia

Study Overview
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Brief Summary
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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.

Official Title
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RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia

Conditions
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Hemodialysis Catheter-related Bacteremia

Intervention / Treatment
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* Drug: tigecycline, N-acetylcysteine, heparin combination
* Device: guide-wire exchange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter with bacteremia will be eligible for enrollment. Exclusion Criteria: The following patients will be excluded: 1) patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent, 2) patient is allergic to NAC, tigecycline, minocycline, or heparin, 3) patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors, 4) patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema, 5) patient is pregnant or will become pregnant, 6) the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic Lock Solution<br> | Drug: tigecycline, N-acetylcysteine, heparin combination<br> <br> |
| Active Comparator: Guide-wire Exchange<br> | Device: guide-wire exchange<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | 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). | 28 days |