Antifungal Locks to Treat Fungal-related Central Line Infections

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bill McGhee; University of Pittsburgh
• Collaborator: Astellas Pharma Inc
• Treatments: Amphotericin B; Antifungal Agents; Liposomal amphotericin B; Miconazole

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