Antifungal Locks to Treat Fungal-Related Central Line Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00936910
First received: July 2, 2009
Last updated: July 8, 2009
Last verified: July 2009
  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 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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Pittsburgh:

Primary Outcome Measures:
  • The success of antifungal lock therapy (the primary endpoint) will be determined by whether or not the patient has at least 2 negative fungal cultures and the CVC was not removed. [ Time Frame: 5 days of antifungal lock treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of days before the infected central line culture becomes negative [ Time Frame: 5 days of antifungal lock treatment ] [ Designated as safety issue: No ]
  • The development of fungal-related complications [ Time Frame: Usually 14-28 days ] [ Designated as safety issue: Yes ]
  • Test of cure catheter cultures on day 5 and day 30 post antifungal lock [ Time Frame: 45-55 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2006
Estimated Study Completion Date: September 2010
Estimated 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
Drug: amphotericin B liposomal (Ambisome)
After enrollment, antifungal therapy will be instituted consisting of both IV systemic and antifungal lock therapy. Systemic therapy will be 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 up to 2.3 ml of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
Other Name: Ambisome

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  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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.
  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: NCT00936910

Contacts
Contact: Bill McGhee, PharmD 412-692-5733 william.mcghee@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15201
Contact: Bill McGhee, PharmD    412-692-5733    william.mcghee@chp.edu   
Sub-Investigator: Mike Green, MD         
Sub-Investigator: Fuchs Julie, MD         
Sub-Investigator: Martin Judy, MD         
Sub-Investigator: Mazariegos George, MD         
Sub-Investigator: Michaels Marian, MD         
Sub-Investigator: Nowalk Andrew, MD         
Sub-Investigator: Squires Robert, MD         
Sponsors and Collaborators
University of Pittsburgh
Astellas Pharma Inc
Investigators
Principal Investigator: Bill McGhee, PharmD Children's Hospital of Pittsburgh of UPMC
  More Information

Publications:

Responsible Party: Bill McGhee, PharmD/Clinical Pharmacy Specialist, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936910     History of Changes
Other Study ID Numbers: Ambisome Locks at CHP
Study First Received: July 2, 2009
Last Updated: July 8, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mycoses
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Clotrimazole
Miconazole
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014