InfectionPhase 2NCT01539343
Antimicrobial Catheter Lock Solution for the Treatment of Central Line Associated Bloodstream Infection (CLABSI)
A Phase 2 study testing Antimicrobial Solution in people with Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the CVC usually needs to be replaced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Antimicrobial Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Patients with indwelling CVC that have been in place for at least 14 days with documented CLABSI as defined by CDC [62]. In neutropenic patients (defined as an absolute neutrophil count (ANC) < 500 cells/mm3) with CLABSI, to confirm that CVC is the source of the bacteremia, we will use the definitions of catheter-related bloodstream infection (CRBSI) based on the mgmt guidelines of intravascular catheter related infections published by IDSA [10]. This includes the evidence that points to the CVC as the culprit: a) Paired quantitative blood cultures (QBC), whereby QBC are drawn through the CVC and peripheral vein and the blood cultures from the CVC reveal 3-fold greater number of colonies than the peripherally drawn QBC. b) Differential time to positivity, where blood cultures simultaneously drawn from the CVC and peripheral vein are positive for the same organism, and the catheter-drawn blood culture turns positive at least 2 hours earlier than the peripherally drawn blood culture.
- Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons: a) Postmenopausal for at least one year b) Post-hysterectomy and/or post-bilateral ovariectomy and/or other surgical sterilization c) If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test within 5 days prior to study enrollment and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
- Patients with short term non-tunneled catheters will be enrolled only if CVC cannot be removed or exchanged (patient refuses to have CVC removed, CVC needed and no other vascular access available, patient is thrombocytopenic (platelet count below 20,000) that will prohibit inserting a new CVC at a different site).
Who cannot join
- Patients allergic to tetracycline antibiotics or calcium EDTA
- Patients on disulfiram or disulfiram like drugs
- Patients with severe sepsis, septic shock, hypotension or who are considered otherwise unstable
- Presence of prosthetic valve
- Presence of signs of metastatic deep-seated infection such as osteomyelitis or septic pulmonary infarcts or endocarditis (as evidenced by vegetations on an echocardiogram), or septic thrombosis
- Patients with tunnel or catheter exit site infection or infusion port pocket abscess as manifested by purulence at the exit site or inflammation with erythema or induration of >1 cm in diameter.
- Patients with Candida line infection
- Patients who have been previously entered on the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Pilot Study to Estimate the Adverse Events Associated With the Lock Solution When Used to Salvage Central Venous Catheter (CVC) in the Setting of a Central Line Associated Bloodstream Infection (CLABSI)
A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the CVC usually needs to be replaced.
The goal of this clinical research study is to learn if an antimicrobial catheter lock solution can make it possible for the CVC to stay in place while treating an infection with antibiotics. The safety of the solution will also be tested.
Read more
Your outcome will be compared to the outcome of patients who had the same type of infection but had their CVC removed.
The antimicrobial catheter lock solution is made up of 3 chemicals:
Minocycline and ethanol are designed to disinfect the CVC. Disodium ethylenediaminetetraacetate is designed to prevent the CVC from clogging.
Read the detailed description
Study Drug Administration (Lock Solution):
If you are found to be eligible to take part in this study, the infection will be treated with antibiotics according to the standard of care. You will also receive the antimicrobial catheter lock solution through the CVC 2 hours per day for at least 5 days within the first week. In addition, you will receive the lock therapy for 2 additional days that could either be given on the following next 2 days or within the next 2 weeks. After locking the catheter for 2 hours, the HEAL lock will be cleared out, and the catheter will be flushed with normal saline and then locked with heparin or normal saline until the next time it needs to be used.
Study Visits:
On the first day after you receive the antimicrobial catheter lock solution, you will be checked for side effects such as pain, burning, discomfort, drowsiness, headache, facial redness, shortness of breath, and/or irregular heartbeat . After the last dose of receiving the catheter lock solution, you will be asked if you have experienced any side effects after receiving the catheter lock solution.
One (1) time each day while you are in the hospital, you will be checked for signs of infection and your vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured.
Every 2 days, blood (about 2 tablespoons) will be drawn to check for infection. This will continue until the blood draws no longer show signs of infection.
Every week, blood (about one teaspoon) will be drawn to check that your liver is function well.
Length of Study Participation:
You may receive the antimicrobial catheter lock solution for up to 7 days (over the course of 3 weeks). You will no longer be able to receive it if intolerable side effects occur or the infection does not go away after 7 days.
End of Treatment Visit:
- You will need to return to MD Anderson for your end of treatment visit within 7 days (+/- 3 days) after your last dose of study drug.
- At this visit, you will be asked about any symptoms or illnesses that you may have had since your last visit. You will be checked for signs of infection and your vital signs will be measured.
- Blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs or therapies that you may be taking until the end of your treatment.
Follow-Up Visit:
You will have a follow-up visit about 1 month after receiving the last dose of antimicrobial catheter lock solution. At this visit, you will be checked for signs of infection and your vital signs will be measured. If the doctor thinks it is needed, blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs that you may be taking until the end of your treatment.
This is an investigational study. The study lock solution is made up of minocycline, disodium ethylenediaminetetraacetate, and ethanol. Each of these are commercially available and FDA approved for other uses:
- Minocycline - for the treatment of cellulitis, acne, respiratory and urinary tract infections, gonococcal, chlamydial or ureaplasma urealyticum infections, cutaneous nocardiosis, and syphilis.
- Disodium ethylenediaminetetraacetate - for the treatment of lead poisoning
- Ethanol - for cleaning your hands
It is investigational to give minocycline, disodium ethylenediaminetetraacetate, and ethanol in combination as an antimicrobial lock solution.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Infection
- Being tested
- Antimicrobial Solution
- Keywords
- Infection, Catheter-related bloodstream infection, CRBSI, Antimicrobial Lock Therapy, ALT, Central Line Associated Bloodstream Infection, CLABSI, Central Venous Catheter, CVC, Quantitative blood cultures, QBC
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial SolutionDrug
Antimicrobial solution, consisting of minocycline in combination with 30mg/ml of a chelator (EDTA) in 25% ethanol solution (HEAL solution), instilled in central venous catheter (CVC) catheter for 2 hours once daily for a minimum of 5 consecutive days. Lock therapy also received once weekly for two additional weeks.
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Lock Solution | Experimental | Participants receive the HEAL antimicrobial solution for 2 hours once daily for a minimum of 5 consecutive days. Participants also receive the lock therapy once weekly for two additional weeks. Principle ingredients include minocycline, calcium disodium ethylenediaminetetraacetate (CaEDTA) and ethanol. Receives: Drug: Antimicrobial Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
Adverse events include symptoms of discomfort and pain associated with antimicrobial lock therapy (ALT) as well as mechanical complications. Evaluation of symptoms of discomfort related to the ALT including pain, feelings of discomfort, irritation, headache, facial redness or flushing, feeling of drowsiness, nausea, alcohol taste, dyspnea, arrhythmias. Participants given a 0 to 10 numeric discomfort scale. Toxicity due to persistent bacteremia monitored at 7 days.
Measured: 7 days
Secondary outcomes (1)
Resolution Efficacy of CLABSI
Clinical assessment pertaining to central line associated bloodstream infection (CLABSI) performed within one month from end of treatment with lock therapy. Following criteria represent infectious failure to respond: Persistent signs and symptoms associated with CLABSI (fever) after 72 hours of initiation of active systemic antimicrobial therapy. Persistent bacteremia. Relapse of bacteremia during follow-up. Development of related deep seated infections during follow-up. Infection related death during acute illness, relapse or development of related deep seated complications.
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
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 InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Triax
- Responsible party
- Sponsor
- Investigators
- Ann-Marie Chaftari, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539343
- Sponsor's protocol ID
- 2011-1019
- Other IDs
- NCI-2012-00302
- Status last verified
- Apr 2016
- First submitted
- 17 Feb 2012
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Raad I, Chaftari AM, Zakhour R, Jordan M, Al Hamal Z, Jiang Y, Yousif A, Garoge K, Mulanovich V, Viola GM, Kanj S, Pravinkumar E, Rosenblatt J, Hachem R. Successful Salvage of Central Venous Catheters in Patients with Catheter-Related or Central Line-Associated Bloodstream Infections by Using a Catheter Lock Solution Consisting of Minocycline, EDTA, and 25% Ethanol. Antimicrob Agents Chemother. 2016 May 23;60(6):3426-32. doi: 10.1128/AAC.02565-15. Print 2016 Jun.
PubMed 27001822
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study to Estimate the Adverse Events Associated With the Lock Solution When Used to Salvage Central Venous Catheter (CVC) in the Setting of a Central Line Associated Bloodstream Infection (CLABSI)
- ClinicalTrials.gov ID
- NCT01539343
- Acronym / sponsor ID
- 2011-1019
- Conditions
- Infection
- Keywords
- Infection, Catheter-related bloodstream infection, CRBSI, Antimicrobial Lock Therapy, ALT, Central Line Associated Bloodstream Infection, CLABSI, Central Venous Catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Triax
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Feb 2012 (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.
A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the CVC usually needs to be replaced.
The goal of this clinical research study is to learn if an antimicrobial catheter lock solution can make it possible for the CVC to stay in place while treating an infection with antibiotics. The safety of the solution will also be tested.
Your outcome will be compared to the outcome of patients who had the same type of infection but had their CVC removed.
The antimicrobial catheter lock solution is made up of 3 chemicals:
Minocycline and ethanol are designed to disinfect the CVC. Disodium ethylenediaminetetraacetate is designed to prevent the CVC from clogging.
Detailed description
Study Drug Administration (Lock Solution):
If you are found to be eligible to take part in this study, the infection will be treated with antibiotics according to the standard of care. You will also receive the antimicrobial catheter lock solution through the CVC 2 hours per day for at least 5 days within the first week. In addition, you will receive the lock therapy for 2 additional days that could either be given on the following next 2 days or within the next 2 weeks. After locking the catheter for 2 hours, the HEAL lock will be cleared out, and the catheter will be flushed with normal saline and then locked with heparin or normal saline until the next time it needs to be used.
Study Visits:
On the first day after you receive the antimicrobial catheter lock solution, you will be checked for side effects such as pain, burning, discomfort, drowsiness, headache, facial redness, shortness of breath, and/or irregular heartbeat . After the last dose of receiving the catheter lock solution, you will be asked if you have experienced any side effects after receiving the catheter lock solution.
One (1) time each day while you are in the hospital, you will be checked for signs of infection and your vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured.
Every 2 days, blood (about 2 tablespoons) will be drawn to check for infection. This will continue until the blood draws no longer show signs of infection.
Every week, blood (about one teaspoon) will be drawn to check that your liver is function well.
Length of Study Participation:
You may receive the antimicrobial catheter lock solution for up to 7 days (over the course of 3 weeks). You will no longer be able to receive it if intolerable side effects occur or the infection does not go away after 7 days.
End of Treatment Visit:
- You will need to return to MD Anderson for your end of treatment visit within 7 days (+/- 3 days) after your last dose of study drug.
- At this visit, you will be asked about any symptoms or illnesses that you may have had since your last visit. You will be checked for signs of infection and your vital signs will be measured.
- Blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs or therapies that you may be taking until the end of your treatment.
Follow-Up Visit:
You will have a follow-up visit about 1 month after receiving the last dose of antimicrobial catheter lock solution. At this visit, you will be checked for signs of infection and your vital signs will be measured. If the doctor thinks it is needed, blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs that you may be taking until the end of your treatment.
This is an investigational study. The study lock solution is made up of minocycline, disodium ethylenediaminetetraacetate, and ethanol. Each of these are commercially available and FDA approved for other uses:
- Minocycline - for the treatment of cellulitis, acne, respiratory and urinary tract infections, gonococcal, chlamydial or ureaplasma urealyticum infections, cutaneous nocardiosis, and syphilis.
- Disodium ethylenediaminetetraacetate - for the treatment of lead poisoning
- Ethanol - for cleaning your hands
It is investigational to give minocycline, disodium ethylenediaminetetraacetate, and ethanol in combination as an antimicrobial lock solution.
Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Lock Solution | Experimental | Drug: Antimicrobial SolutionParticipants receive the HEAL antimicrobial solution for 2 hours once daily for a minimum of 5 consecutive days. Participants also receive the lock therapy once weekly for two additional weeks. Principle ingredients include minocycline, calcium disodium ethylenediaminetetraacetate (CaEDTA) and ethanol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Patients with indwelling CVC that have been in place for at least 14 days with documented CLABSI as defined by CDC [62]. In neutropenic patients (defined as an absolute neutrophil count (ANC) < 500 cells/mm3) with CLABSI, to confirm that CVC is the source of the bacteremia, we will use the definitions of catheter-related bloodstream infection (CRBSI) based on the mgmt guidelines of intravascular catheter related infections published by IDSA [10]. This includes the evidence that points to the CVC as the culprit: a) Paired quantitative blood cultures (QBC), whereby QBC are drawn through the CVC and peripheral vein and the blood cultures from the CVC reveal 3-fold greater number of colonies than the peripherally drawn QBC. b) Differential time to positivity, where blood cultures simultaneously drawn from the CVC and peripheral vein are positive for the same organism, and the catheter-drawn blood culture turns positive at least 2 hours earlier than the peripherally drawn blood culture.
- Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons: a) Postmenopausal for at least one year b) Post-hysterectomy and/or post-bilateral ovariectomy and/or other surgical sterilization c) If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test within 5 days prior to study enrollment and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
- Patients with short term non-tunneled catheters will be enrolled only if CVC cannot be removed or exchanged (patient refuses to have CVC removed, CVC needed and no other vascular access available, patient is thrombocytopenic (platelet count below 20,000) that will prohibit inserting a new CVC at a different site).
Key exclusion criteria (8 listed)
- Patients allergic to tetracycline antibiotics or calcium EDTA
- Patients on disulfiram or disulfiram like drugs
- Patients with severe sepsis, septic shock, hypotension or who are considered otherwise unstable
- Presence of prosthetic valve
- Presence of signs of metastatic deep-seated infection such as osteomyelitis or septic pulmonary infarcts or endocarditis (as evidenced by vegetations on an echocardiogram), or septic thrombosis
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 |
|---|---|---|
| Antimicrobial SolutionAntimicrobial solution, consisting of minocycline in combination with 30mg/ml of a chelator (EDTA) in 25% ethanol solution (HEAL solution), instilled in central venous catheter (CVC) catheter for 2 hours once daily for a minimum of 5 consecutive days. Lock therapy also received once weekly for two additional weeks. | Drug | Antimicrobial Lock Solution |
Primary outcome
Adverse Event Rate
Time frame: 7 days
Adverse events include symptoms of discomfort and pain associated with antimicrobial lock therapy (ALT) as well as mechanical complications. Evaluation of symptoms of discomfort related to the ALT including pain, feelings of discomfort, irritation, headache, facial redness or flushing, feeling of drowsiness, nausea, alcohol taste, dyspnea, arrhythmias. Participants given a 0 to 10 numeric discomfort scale. Toxicity due to persistent bacteremia monitored at 7 days.
1 secondary outcome
Resolution Efficacy of CLABSI
Time frame: 1 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Derived from this study: PubMed 27001822Raad I, Chaftari AM, Zakhour R, Jordan M, Al Hamal Z, Jiang Y, Yousif A, Garoge K, Mulanovich V, Viola GM, Kanj S, Pravinkumar E, Rosenblatt J, Hachem R. Successful Salvage of Central Venous Catheters in Patients with Catheter-Related or Central Line-Associated Bloodstream Infections by Using a Catheter Lock Solution Consisting of Minocycline, EDTA, and 25% Ethanol. Antimicrob Agents Chemother. 2016 May 23;60(6):3426-32. doi: 10.1128/AAC.02565-15. Print 2016 Jun.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ann-Marie Chaftari, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antimicrobial Solution in people with Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 18 Apr 2016. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Rate (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 NCT01539343, 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 18 Apr 2016.