Trial Outcomes & Findings for Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection (NCT NCT02095951)

NCT ID: NCT02095951

Last Updated: 2018-12-19

Results Overview

A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
• Results posted on: 2018-12-19

Participant Flow

135 episodes screened, but only 36 initially met enrollment criteria. 27 unique patients were enrolled for 33 episodes (6 patients enrolled twice) of possible catheter infection.

3 enrolled participants were removed from the study/analysis for failure to meet final enrollment criteria. Patient participants could be re-enrolled in the study more than once if their infection episodes (cases) were separated by at least 28 days.

Unit of analysis: Catheter Infection Episodes (Cases)

Participant milestones

Measure	Pre-emptive Ethanol Lock Therapy Group Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.	Standard Ethanol Lock Therapy Group Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
Overall Study STARTED	13 15	14 18
Overall Study COMPLETED	4 5	8 9
Overall Study NOT COMPLETED	9 10	6 9

Reasons for withdrawal

Measure	Pre-emptive Ethanol Lock Therapy Group Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.	Standard Ethanol Lock Therapy Group Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
Overall Study NO POSITIVE BLOOD CULTURE	9	6

Baseline Characteristics

Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection

Baseline characteristics by cohort

Measure	Pre-emptive Ethanol Lock Therapy Group n=13 Participants Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative.	Standard Ethanol Lock Therapy Group n=14 Participants Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.	Total n=27 Participants Total of all reporting groups
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Age, Categorical <=18 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheter Infection Episodes (cases) Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheter Infection Episodes (cases) Standard of Care Ethanol Lock Therapy group
Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases	124 HOURS Standard Deviation 51	208 HOURS Standard Deviation 151

PRIMARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheter Infection Episodes (cases) Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheter Infection Episodes (cases) Standard of Care Ethanol Lock Therapy group
Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases	21 HOURS Standard Deviation 20	32 HOURS Standard Deviation 12

PRIMARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

Hospital COSTS

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheters Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheters Standard of Care Ethanol Lock Therapy group
Hospital COSTS in 14 Confirmed Catheter Related Infection Cases	11,441 USD $ Standard Deviation 3722	18,071 USD $ Standard Deviation 3739

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

Number of Catheters sterilized with interventions

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheters Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheters Standard of Care Ethanol Lock Therapy group
Catheter Sterilization	5 Catheters	9 Catheters

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

Number of Infected catheters (which achieved sterilization) with salvage for at least 14 days.

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheters Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheters Standard of Care Ethanol Lock Therapy group
Catheter Salvage	5 Catheters	9 Catheters

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but up to 1 month post the last ethanol dose administration

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

Number of Adverse events per episode of distinct catheter infection that are thought to be related to the actual study intervention, namely timing of ethanol lock placement, will be reviewed and reported for each individual infection episode/admission.

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheter Infection Episodes (cases) Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheter Infection Episodes (cases) Standard of Care Ethanol Lock Therapy group
Number of Adverse Events Per Episode of Catheter Infection	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total

Population: 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.

Number of Re-Infected of salvaged catheters with same or new organism(s) within 28 days of prior CRI/ELT

Outcome measures

Measure	Pre-emptive Ethanol Lock Therapy Group n=5 Catheters Pre-emptive Ethanol Lock Therapy Group	Standard of Care Ethanol Lock Therapy Group n=9 Catheters Standard of Care Ethanol Lock Therapy group
Re-infection	0 Catheters	0 Catheters

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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

Eric McGrath, MD

Wayne State University School of Medicine - Children's Hosp. of Michigan

Phone: 313-745-5862

Email: emcgrath@med.wayne.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place