Phase 4
N=13
Antifungal Locks to Treat Fungal-related Central Line Infections
Central Line Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00936910 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: 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 — 10; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- amphotericin B liposomal (Ambisome) (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Bill McGhee
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
10; 3 | — |
| SECONDARY The Number of Days Before the Infected Central Line Culture Becomes Negative |
2.4 | — |
| SECONDARY The Development of Fungal-related Complications |
— | — |
| SECONDARY Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock |
5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00936910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.