Trial Outcomes & Findings for Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection (NCT NCT01472965)
NCT ID: NCT01472965
Last Updated: 2017-11-13
Results Overview
Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
Up to 25 weeks after the start of treatment.
Results posted on
2017-11-13
Participant Flow
Participants meeting eligibility criteria were enrolled between December 2011 and August 2016. They were randomized to receive catheter lock therapy using either 70% ethanol or heparin-saline (placebo). Randomization was blinded to the participant, their care provider, the investigator, and the outcomes assessor.
Participant milestones
| Measure |
Treatment (Ethanol)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
46
|
|
Overall Study
COMPLETED
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment (Ethanol)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
Baseline characteristics by cohort
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
8.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
8.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 25 weeks after the start of treatment.Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone
|
43.8 percentage of participants
|
43.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 25 weeks after the start of treatmentTherapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for \>72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The cumulative incidence of therapeutic failure is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
|
44.0 percentage of participants
|
43.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 25 weeks after the start of treatmentRelapse was defined as new CLABSI with an identical organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with relapse is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
|
6.3 percentage of participants
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 25 weeks after the start of treatment.Reinfection was defined as new CLABSI with a different organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with reinfection is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
|
27.3 percentage of participants
|
24.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after the start of treatment.Occlusion was defined as central line occlusion or dysfunction requiring thrombolytic therapy. The percentage of evaluable participants requiring thrombolytic therapy for central line occlusion is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
|
58.3 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 37.5 weeks after the start of treatment.Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record. The percentage of evaluable participants with any potentially attributable adverse effect is reported.
Outcome measures
| Measure |
Treatment (Ethanol)
n=48 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 Participants
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
|
60.4 percentage of participants
|
39.1 percentage of participants
|
Adverse Events
Treatment (Ethanol)
Serious events: 6 serious events
Other events: 4 other events
Deaths: 3 deaths
Control (Placebo)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Ethanol)
n=48 participants at risk
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 participants at risk
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
Product Issues
Line fracture or split
|
12.5%
6/48 • Number of events 6 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
8.7%
4/46 • Number of events 4 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/48 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
2.2%
1/46 • Number of events 1 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
Other adverse events
| Measure |
Treatment (Ethanol)
n=48 participants at risk
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol catheter lock therapy.
ethanol: 70% ethanol catheter lock therapy
|
Control (Placebo)
n=46 participants at risk
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with heparin-saline placebo catheter lock therapy.
heparin-saline placebo: heparin-saline placebo catheter lock therapy
|
|---|---|---|
|
General disorders
Chest pain (infusional)
|
8.3%
4/48 • Number of events 4 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
0.00%
0/46 • Adverse events were collected from on study date through through off study date (up to 263 days).
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record.
|
Additional Information
Joshua Wolf, MBBS, BA
St. Jude Children's Research Hospital
Phone: 901-595-1475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place