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Treatment of Hemodialysis Catheter-Related Bacteremia

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ClinicalTrials.gov Identifier: NCT02040818
Recruitment Status : Withdrawn (no enrollment)
First Posted : January 20, 2014
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


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 Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Antibiotic Lock Solution Drug: tigecycline, N-acetylcysteine, heparin combination
Active Comparator: Guide-wire Exchange Device: guide-wire exchange


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
University of California, San Diego Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
More Information

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:
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