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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Infection

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Trial Information

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.

Study Visits:

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
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.


Inclusion Criteria:



1. Patients aged 18 years or older

2. 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.

3. 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 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.

4. 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).

Exclusion Criteria:

1. Patients allergic to tetracycline antibiotics or calcium EDTA

2. Patients on disulfiram or disulfiram like drugs

3. Patients with severe sepsis, septic shock, hypotension or who are considered
otherwise unstable

4. Presence of prosthetic valve, implanted intravascular devices (e.g., pacemakers),
prosthetic joints.

5. 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

6. 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.

7. Patients with Candida line infection

8. Patients who have been previously entered on the study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Event Rate

Outcome Description:

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.

Outcome Time Frame:

7 days

Safety Issue:

No

Principal Investigator

Issam Raad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-1019

NCT ID:

NCT01539343

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Infection
  • Infection
  • Catheter-related bloodstream infection
  • CRBSI
  • Antimicrobial Lock Therapy
  • ALT
  • Central Line Associated Bloodstream Infection
  • CLABSI
  • Central Venous Catheter
  • CVC
  • Quantitative blood cultures
  • QBC

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030