drugset / Trial / NCT00936910

Antifungal Locks to Treat Fungal-related Central Line Infections

NCT00936910

Phase 4 Completed 13 enrolled Bill McGhee Astellas Pharma Inc · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-09
Primary completion
2010-08
Completion
2010-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 2 mg/ml Intravenous
Subject Amphotericin B Unknown 2.3 ml Intravenous
Subject Amphotericin B Unknown 3 mg/kg Intravenous
Subject Amphotericin B Unknown 5 mg/kg Intravenous