Trial Outcomes & Findings for Antifungal Locks to Treat Fungal-related Central Line Infections (NCT NCT00936910)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

5 days of antifungal lock treatment

Results posted on

2017-10-10

Participant Flow

Children were considered for enrollment if they had chronic intestinal insufficiency (including intestinal transplantation) and/or the presence of long term central venous access, and one or more positive blood cultures for yeast attributed to the central line

Participant milestones

Participant milestones
Measure	Antifungal Lock-treated Patients This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Antifungal Lock-treated Patients This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
Overall Study Lack of Efficacy	3

Baseline Characteristics

Antifungal Locks to Treat Fungal-related Central Line Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Patients n=13 Participants Patients enrolled had intestinal insufficiency (including intestinal transplantation) and/or the presence of long term central venous access, and one or more positive cultures for yeast attributed to the central line. Patients were excluded if they hypotension at the time of enrollment or need for ICU support.
Age, Continuous	7.8 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
All patients with fungal catheter-related blood stream infections were potential study subjects	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days of antifungal lock treatment

Population: 13 children with long term central line venous access with positive central line fungal infections were enrolled in the trial.

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

Outcome measures

Outcome measures
Measure	Antifungal Lock-treated Patients n=13 Participants This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
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 number of patients with negative culture	10 Participants
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 number of patients with positive cultures	3 Participants

SECONDARY outcome

Timeframe: 5 days of antifungal lock treatment

Population: All children with long term venous access with central line fungal related infections were eligible for enrollment in the trial. No one was excluded because of age, sex, or ethinicity

Records the mean number of days required for the cultures to become negative

Outcome measures

Outcome measures
Measure	Antifungal Lock-treated Patients n=13 Participants This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
The Number of Days Before the Infected Central Line Culture Becomes Negative	2.4 days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Usually 1-28 days

Population: All children with long term central line access with fungal-related central line infections were eligible for enrollment. No one was excluded due to sex, age, race, or ethnicity

Records the number of fungal related adverse complications that occurred

Outcome measures

Outcome measures
Measure	Antifungal Lock-treated Patients n=13 Participants This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
The Development of Fungal-related Complications	0 adverse complications

SECONDARY outcome

Timeframe: 30 days

Population: All children with long term venous access with fungal related central line infections were eligible for enrollment in the trial. No one was excluded because of age, sex, race or ethnicity.

Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30

Outcome measures

Outcome measures
Measure	Antifungal Lock-treated Patients n=13 Participants This is a single arm non-randomized study consisting primarily of intestinal failure and other patients with poor IV access and central line fungal infections After enrollment, antifungal therapy consisted of both IV systemic and antifungal lock therapy. Systemic therapy was Ambisome (or other antifungal based upon standard of care) administered IV in a dose of 3-5 mg/kg/day combined with antifungal lock therapy. The antifungal lock therapy involved placing a catheter-specific volume (\<= 2.3 ml) of concentrated Ambisome (2 mg/ml) into the infected central venous catheter (CVC) and allowing it to dwell uninterruptedly for 8 to 12 hours per day for 10-14 days.
Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock	5 participants

Adverse Events

Antifungal Lock-treated Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William McGhee, Clinical Pharmacy Specialist, Transplant

Children's Hospital of Pittburgh

Phone: 412-692-5733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place