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NCT01483872 · ClinicalTrials.gov registry record · Phase 3

Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

A Phase 3 study, sponsored by University of California, San Diego.

Terminated
Registry status
Phase 3
Development phase
9
Enrollment target

NCT01483872 is a Phase 3 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 9 participants.

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The verdict

NCT01483872, a Phase 3 study, was terminated before completion, sponsored by University of California, San Diego.

TERMINATED
Registry status
Phase 3
Development phase
9 participants
Enrollment target

Study Summary

Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy. The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.

Interventions

  • DRUG NAC/Tigecycline/Heparin combination lock solution
  • DRUG Standard anticoagulant (Heparin or Citrate)

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2012-03
Est. Completion 2013-09
Phase Phase 3

Sponsor

University of California, San Diego

775 total trials

What the Registry Record Tells You About NCT01483872

The ClinicalTrials.gov registry entry for NCT01483872 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which NAC/Tigecycline/Heparin combination lock solution is the first listed.

NCT01483872 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01483872 about?

NCT01483872 is a clinical study titled "Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections". Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-sal...

What is the current status of trial NCT01483872?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2012-03. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01483872?

The interventions under investigation include: NAC/Tigecycline/Heparin combination lock solution (DRUG), Standard anticoagulant (Heparin or Citrate) (DRUG).

Who is sponsoring clinical trial NCT01483872?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.