BacteremiaPhase 3NCT01186172
Ethanol Lock for the Salvage of Infected Long-term Vascular Access
A Phase 3 study testing Ethanol-lock therapy and Antibiotic-lock in people with Bacteremia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Ethanol-lock therapy and Antibiotic-lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: >1 year and 10 Kgs
- Long-term vascular device in place at least for 7 days
- Catheter-related infection (at least presumed)
- Will to save the infected device (expected high risk access)
Who cannot join
- Known ethanol-allergy
- Known antabuse-like drugs in use
- Religious refusal
- S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
- Tract or pocket infection
- Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico "San Matteo"
Pavia, PV, 27100
Michele Pagani, M.D.
Andrea Bottazzi, M.D.
About this study
Official title: Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.
- Conditions
- Bacteremia
- Being tested
- Ethanol-lock therapy, Antibiotic-lock
- Keywords
- ethanol, lock therapy, vascular access, central venous catheter, sepsis
- Medical subject headings
- Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol-lock therapyDrug
Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
Antibiotic-lockDrug
Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Ethanol-lock | Experimental | Treatment with a combination of ethanol-lock and parenteral therapy Receives: Drug: Ethanol-lock therapy |
| Antibiotic lock | Active comparator | Treatment with a combination of antibiotic-lock and parenteral therapy Receives: Drug: Antibiotic-lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of saved devices
Measured: 7 days
Secondary outcomes (4)
Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability
Major adverse event (stop protocol): anaphylaxis, antabuse-like reaction, device damage, severe dysphoric reaction.
Minor adverse events (do not stop protocol): nausea, vomiting, headache, dizziness.
Measured: 60 days
Number of patients with proper parenteral therapy
Verified by an Infectious Diseases Specialist
Measured: 7 days
Ratio of saved devices
Measured: 15-30-60 days
Time for next bacteriemic episode
Measured: 30 days after the end of lock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Pagani, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Michele Pagani, M.D., Principal investigator, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186172
- Sponsor's protocol ID
- ETHCVC
- Status last verified
- Jan 2012
- First submitted
- 17 Aug 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162.
PubMed 19803767
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato
- ClinicalTrials.gov ID
- NCT01186172
- Acronym / sponsor ID
- ETHCVC
- Conditions
- Bacteremia
- Keywords
- ethanol, lock therapy, vascular access, central venous catheter, sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol-lock | Experimental | Drug: Ethanol-lock therapyTreatment with a combination of ethanol-lock and parenteral therapy |
| Antibiotic lock | Active comparator | Drug: Antibiotic-lockTreatment with a combination of antibiotic-lock and parenteral therapy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: >1 year and 10 Kgs
- Long-term vascular device in place at least for 7 days
- Catheter-related infection (at least presumed)
- Will to save the infected device (expected high risk access)
Key exclusion criteria (6 listed)
- Known ethanol-allergy
- Known antabuse-like drugs in use
- Religious refusal
- S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)
- Tract or pocket infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol-lock therapyDaily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days. | Drug | Ethanol-lock |
| Antibiotic-lockDaily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days. | Drug | Antibiotic lock |
Primary outcome
Ratio of saved devices
Time frame: 7 days
4 secondary outcomes
Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability
Time frame: 60 days
Number of patients with proper parenteral therapy
Time frame: 7 days
Ratio of saved devices
Time frame: 15-30-60 days
Time for next bacteriemic episode
Time frame: 30 days after the end of lock
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Background: PubMed 19803767Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162.
Related trials for Bacteremia
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Pagani, M.D. principal investigator
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethanol-lock therapy and Antibiotic-lock in people with Bacteremia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Pagani, MD (+390382502767, m.pagani@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of saved devices (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2012.