Antifungal Locks to Treat Fungal-related Central Line Infections
|ClinicalTrials.gov Identifier: NCT00936910|
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : October 10, 2017
Last Update Posted : October 10, 2017
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 or disease||Intervention/treatment||Phase|
|Central Line Fungal Infections||Drug: amphotericin B liposomal (Ambisome)||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Antifungal Lock Therapy in Intestinal Failure and Other Patients|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936910
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Bill McGhee, PharmD||Children's Hospital of Pittsburgh of UPMC|