Treatment of Hemodialysis Catheter-Related Bacteremia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Saima Aslam, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02040818
First received: January 16, 2014
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hemodialysis Catheter-related Bacteremia
Drug: tigecycline, N-acetylcysteine, heparin combination
Device: guide-wire exchange
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Official Title: RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Treatment Success [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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).


Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic Lock Solution Drug: tigecycline, N-acetylcysteine, heparin combination
Active Comparator: Guide-wire Exchange Device: guide-wire exchange

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02040818

Contacts
Contact: Saima Aslam, MD, MS (619)543-6327 saslam@ucsd.edu

Locations
United States, California
University of California, San Diego Medical Center Not yet recruiting
San Diego, California, United States, 92103
Contact: Saima Aslam, MD, MS    619-543-6327    saslam@ucsd.edu   
Principal Investigator: Saima Aslam, MD, MS         
Sponsors and Collaborators
University of California, San Diego
  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
Study First Received: January 16, 2014
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
United States: Federal Government

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Acetylcysteine
Tigecycline
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014