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Antifungal Locks to Treat Fungal-related Central Line Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936910
First Posted: July 10, 2009
Last Update Posted: October 10, 2017
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.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Bill McGhee, University of Pittsburgh
  Purpose

The purpose of this study is to evaluate the usefulness of antifungal lock therapy with liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients with catheter-related blood stream infections with fungal organisms, whose catheter has not been removed because of the continuing critical need for central line access. The primary group of potential patients will be those with intestinal insufficiency, including post-op small bowel transplant recipients.

The recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last positive culture. However, in certain intestinal failure patients, removal of an infected line might significantly reduce or eliminate intravenous (IV) access and create a life threatening situation. Thus, the investigators' aim is to determine the usefulness of antifungal lock therapy in intestinal failure patients whose catheter has not been removed. The investigators' hope is to salvage central line catheters rather than to remove them.


Condition Intervention Phase
Central Line Fungal Infections Drug: amphotericin B liposomal (Ambisome) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Antifungal Lock Therapy in Intestinal Failure and Other Patients

Resource links provided by NLM:


Further study details as provided by Bill McGhee, University of Pittsburgh:

Primary Outcome Measures:
  • Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed [ Time Frame: 5 days of antifungal lock treatment ]
    Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed


Secondary Outcome Measures:
  • The Number of Days Before the Infected Central Line Culture Becomes Negative [ Time Frame: 5 days of antifungal lock treatment ]
    Records the mean number of days required for the cultures to become negative

  • The Development of Fungal-related Complications [ Time Frame: Usually 1-28 days ]
    Records the number of fungal related adverse complications that occurred

  • Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock [ Time Frame: 30 days ]
    Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30


Enrollment: 13
Study Start Date: September 2006
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antifungal lock-treated patients
Intestinal failure and other patients with poor IV access and central line fungal-related infections will receive intravenous systemic antifungal therapy plus the instillation of Ambisome locks into the infected catheter.
Drug: amphotericin B liposomal (Ambisome)
After enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy. The antifungal lock therapy consists of placing sufficient amphotericin B liposomal (Ambisome [2 mg/ml]) lock solution into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days (largest CVC = 2.3 mL).
Other Name: Ambisome

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with intestinal insufficiency and central venous access.
  • Culture positive fungal-related CRBSI.
  • Females of childbearing potential will be eligible for the study.
  • Ambisome carries a category B Pregnancy Risk Factor. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant.
  • HIV serostatus will not be determined for the purpose of participating in this study.

Exclusion Criteria:

  • Patients less than 30 days of age
  • Patients greater than 21 years of age
  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): NCT00936910


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Bill McGhee
Astellas Pharma Inc
Investigators
Principal Investigator: Bill McGhee, PharmD Children's Hospital of Pittsburgh of UPMC
  More Information

Publications:

Responsible Party: Bill McGhee, Clinical Pharmacy Specialist - Transplantaton, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936910     History of Changes
Other Study ID Numbers: Ambisome Locks at CHP
First Submitted: July 2, 2009
First Posted: July 10, 2009
Results First Submitted: January 15, 2016
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The entire data for all patients from the clinical trial has been published. The reference is: McGhee W, Michaels M, Martin, J, et al. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial. Journal of the Pediatric Infectious Diseases Society. 2016;5 (1): 80-4.

Keywords provided by Bill McGhee, University of Pittsburgh:
central line fungal infections
antifungal lock therapy
Ambisome lock therapy

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Miconazole
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors