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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00302 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Triax | UNKNOWN |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann-Marie Chaftari, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27001822 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 1 month after treatment |