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)
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 over about 2 hours. After 2 hours, the lock solution
will be removed and the CVC will be flushed with saline solution and replaced with saline or
a heparin lock (the standard of care for this treatment) until the CVC line is used again.
This procedure will be performed 5 days in a row, followed by 2 more times over the course
of 2 weeks.
Each time 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 for 2 hours.
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Issam Raad, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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