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NCT02040818

RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia

Withdrawn Phase 2/Phase 3 Last updated 6 October 2015
What this trial tests

Phase 2/Phase 3 trial testing tigecycline, N-acetylcysteine, heparin combination in Hemodialysis Catheter-related Bacteremia. Withdrawn.

Timeline
1 November 2013
Primary endpoint
1 January 2017

Quick facts

Lead sponsorUniversity of California, San Diego
PhasePhase 2/Phase 3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Maskingnone
Start date1 November 2013
Primary completion1 January 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

Adults 18 to 100, any sex, with Hemodialysis Catheter-related Bacteremia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis.
    Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. · · 2022 · cited 19× · PMID 35363884 · DOI 10.1002/14651858.cd013554.pub2

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