A Phase 3 interventional study of ethanol and heparin-saline placebo in Central Line-Associated Bloodstream Infection, sponsored by St. Jude Children's Research Hospital. Completed at 2 sites in 2 countries. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by St. Jude Children's Research Hospital · Phase 3, Interventional, and Prevention
Use of long-term central venous access devices (including tunneled lines and ports) can be associated with development of bloodstream infection caused by build-up of bacteria or fungus on the inside of the device, called central line associated bloodstream infection (CLABSI). This infection generally requires hospital admission and antibiotic therapy. This treatment usually helps eradicate the infection but sometimes it is not possible to clear or it comes back after treatment. Also, once someone has had one line infection the chance of getting another one is higher. This study will test whether treatment and secondary prophylaxis of CLABSI with ethanol lock therapy (ELT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse or reinfection) in children and adolescents treated for cancer or hematologic disorders or undergoing hematopoietic stem cell transplantation (HSCT). ELT involves injecting a solution of ethanol and water into the line or port, allowing it to dwell for 2 hours, and then withdrawing the solution.
Eligible patients with CLABSI will be enrolled within 96 hours of collection of positive blood culture and randomized to blinded treatment with 70% ethanol or heparin-saline placebo catheter lock therapy.
After enrollment, all subjects will receive catheter lock therapy for a 5 day Treatment Phase, followed by a 24 week Prophylaxis Phase. Participants in the active treatment arm will receive 70% ethanol locks and those in the placebo arm will receive heparin-saline placebo locks in identical fashion.
In addition to the study intervention, participants in both arms will receive standard systemic antibiotic therapy according to the preference of the ward clinician.
The intervention will continue for 24 weeks unless off-therapy criteria are met or the catheter is removed.
After the intervention is discontinued, participants will be monitored for 90 days, or 30 days after line removal, whichever is shorter. If the intervention is discontinued prior to 24 weeks due to adverse event or physician request, participants will be monitored for the remainder of the 24 week period.
Primary Objective:
Secondary Objectives:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 95 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: ethanol
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.
Drug: heparin-saline placebo
70% ethanol catheter lock therapy
Also known as: 70% ethanol
heparin-saline placebo catheter lock therapy
Also known as: heparin-saline
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
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.
Time frame: Up to 25 weeks after the start of treatment.
Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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 cumulative incidence of therapeutic failure is reported.
Time frame: Up to 25 weeks after the start of treatment
Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Relapse 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.
Time frame: Up to 25 weeks after the start of treatment
Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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.
Time frame: Up to 25 weeks after the start of treatment.
Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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.
Time frame: Up to 26 weeks after the start of treatment.
Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
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.
Time frame: Up to 37.5 weeks after the start of treatment.
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.
| Milestone | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Started | 49 | 46 |
| Completed | 48 | 46 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| 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 | 43.5 |
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 cumulative incidence of therapeutic failure is reported.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone | 44.0 | 43.9 |
Relapse 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.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone | 6.3 | 8.7 |
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.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone | 27.3 | 24.4 |
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.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone | 58.3 | 32.6 |
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.
| percentage of participants | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone | 60.4 | 39.1 |
Collected over Adverse events were collected from on study date through through off study date (up to 263 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Ethanol) | 3/48 (6.3%) | 6/48 (12.5%) | 4/48 (8.3%) |
| Control (Placebo) | 4/46 (8.7%) | 5/46 (10.9%) | 0/46 (0%) |
| Event | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Line fracture or splitProduct Issues | 6/48 | 4/46 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/48 | 1/46 |
| Event | Treatment (Ethanol) | Control (Placebo) |
|---|---|---|
| Chest pain (infusional)General disorders | 4/48 | 0/46 |
| Age, Continuous(years) | Treatment (Ethanol) | Control (Placebo) | Total |
|---|---|---|---|
| Mean | 8.8 ± 6.3 | 8.3 ± 6.7 | 8.6 ± 6.4 |
| Sex: Female, Male(Participants) | Treatment (Ethanol) | Control (Placebo) | Total |
|---|---|---|---|
| Female | 14 | 21 | 35 |
| Male | 34 | 25 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Ethanol) | Control (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 8 | 16 |
| Not Hispanic or Latino | 35 | 36 | 71 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Race (NIH/OMB)(Participants) | Treatment (Ethanol) | Control (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 6 | 12 | 18 |
| White | 31 | 30 | 61 |
| More than one race | 4 | 1 | 5 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Treatment (Ethanol) | Control (Placebo) | Total |
|---|---|---|---|
| United States | 42 | 45 | 87 |
| Australia | 6 | 1 | 7 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Jude Children's Research Hospital