Antimicrobial Catheter Lock Solution for the Treatment of Central Line Associated Bloodstream Infection (CLABSI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Triax
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01539343
First received: February 17, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Infection
Drug: Antimicrobial Solution
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Adverse Event Rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Resolution Efficacy of CLABSI [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antimicrobial Lock Solution
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.
Drug: Antimicrobial Solution
Antimicrobial solution, consisting of minocycline in combination with 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539343

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Triax
Investigators
Principal Investigator: Michael Fisch, MD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01539343     History of Changes
Other Study ID Numbers: 2011-1019, NCI-2012-00302
Study First Received: February 17, 2012
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Infection
Catheter-related bloodstream infection
CRBSI
Antimicrobial Lock Therapy
ALT
Central Line Associated Bloodstream Infection
CLABSI
Central Venous Catheter
CVC
Quantitative blood cultures
QBC

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pharmaceutical Solutions
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014