Treatment of Hemodialysis Catheter-Related Bacteremia
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| ClinicalTrials.gov Identifier: NCT02040818 |
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Recruitment Status :
Withdrawn
(no enrollment)
First Posted : January 20, 2014
Last Update Posted : October 8, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemodialysis Catheter-related Bacteremia | Drug: tigecycline, N-acetylcysteine, heparin combination Device: guide-wire exchange | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Masking: | None (Open Label) |
| Official Title: | RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia |
| Study Start Date : | November 2013 |
| Estimated Primary Completion Date : | January 2017 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Antibiotic Lock Solution |
Drug: tigecycline, N-acetylcysteine, heparin combination |
| Active Comparator: Guide-wire Exchange |
Device: guide-wire exchange |
- 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).
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040818
| United States, California | |
| University of California, San Diego Medical Center | |
| San Diego, California, United States, 92103 | |
Publications:
| Responsible Party: | Saima Aslam, Adj Ass Prof, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT02040818 History of Changes |
| Other Study ID Numbers: |
RCT 131309 |
| First Posted: | January 20, 2014 Key Record Dates |
| Last Update Posted: | October 8, 2015 |
| Last Verified: | October 2015 |
Additional relevant MeSH terms:
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Bacteremia Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Heparin Acetylcysteine Tigecycline N-monoacetylcystine Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Protective Agents Physiological Effects of Drugs Antidotes Anti-Bacterial Agents Protein Synthesis Inhibitors Enzyme Inhibitors |