Treatment of Hemodialysis Catheter-Related Bacteremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02040818

Recruitment Status : Withdrawn (no enrollment)

First Posted : January 20, 2014

Last Update Posted : October 8, 2015

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Saima Aslam, University of California, San Diego

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 :

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

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
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:

Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7. doi: 10.1086/590192.


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

To Top