Status:
COMPLETED
Antifungal Locks to Treat Fungal-related Central Line Infections
Lead Sponsor:
Bill McGhee
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Central Line Fungal Infections
Eligibility:
All Genders
30-21 years
Phase:
PHASE4
Brief 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-relat...
Detailed Description
This is a descriptive study in intestinal failure patients with catheter-related blood stream infections (CRBSI) with fungal organisms. At present, the recommendation of the Infectious Disease Society...
Eligibility Criteria
Inclusion
- 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
- Patients less than 30 days of age
- Patients greater than 21 years of age
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00936910
Start Date
September 1 2006
End Date
September 1 2010
Last Update
October 10 2017
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224