A Study of Experimental Mino-Lok Therapy (MLT) for Catheter-Related or Central Line-Associated Bloodstream Infection

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Age: 12 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Bloodstream Infection, catheter-related infection, Central Line-Associated Infection, Central Line-Associated Bloodstream Infection, Catheter-Related Bloodstream Infection
Type: Drug study, Phase 3
Target:
5 Participants
Investigator:
Description
This research study will test the safety and effectiveness of an experimental drug called Mino-Lok Therapy (MLT). It will be combined with standard of care (SOC) intravenous (IV) antibiotic therapy. This treatment will be compared to antibiotic lock in combination with SOC IV antibiotics. It will be used in catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).

The infection is in your central venous catheter (CVC). A CVC is a sterile tube that allows drug to flow from a bottle or bag directly into a patient’s bloodstream. The CVC may get bacteria in it causing an infection to enter the bloodstream.

Typically, when a CRBSI/CLABSI occurs, the CVC is replaced. We hope to learn if MLT makes it possible for the CVC not to have to be replaced while treating the bloodstream infection with antibiotics.

MLT is a combination of minocycline, edetate disodium, and ethanol. Minocycline and ethanol are designed to disinfect the CVC. Edetate disodium is designed to keep the CVC from clogging.

The information we get from this study could help future patients with CRBSI/CLABSIs.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Male or female at least 12 years of age;
  2. Subject must have a bloodstream infection with no other apparent source that is not related to an infection at another site that meets one of the following:
  3. A recognized single pathogen cultured from 1 or more blood cultures; OR
  4. A common skin contaminant cultured from 2 or more blood cultures drawn on the same or consecutive calendar days from a subject with fever (greater than 38.0 degrees C), chills, or hypotension (systolic blood pressure less than 90 mmHg);
  5. Inpatient or outpatient with presence of indwelling CVC (ie, totally implantable port, tunneled or non-tunneled CVC, hemodialysis catheter, or peripherally inserted CVC) that has been in place for greater than5 days from which a bloodstream infection has been documented within 96 hours prior to enrollment (and from which an isolate of the baseline pathogen(s) is still available for analysis at the central laboratory) and demonstrates the protocol definition of CRBSI/CLABSI; NOTE: For the treatment arm only (MLT Arm and Control Arm), the CVC is expected to be in place through the end of treatment.
  6. Subjects who refuse to have their catheter removed or subjects for whom, in the Investigator's opinion, catheter retention for the duration of the study is reasonable or required;
  7. Female subjects of childbearing potential must have a negative urine and/or serum pregnancy test within 5 days prior to randomization (MLT Arm and Control Arm) ;
  8. Male subjects must agree to refrain from sperm donation throughout the duration of the study and for 90 days following the last dose of study drug;
  9. Subjects eligible for the Observation Arm must have had their central line removed and replaced within 96 hours of the qualifying blood culture (120 hours with Medical Monitor approval);

Exclusion criteria:

  1. Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium; .
  2. Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
  3. Subjects taking disulfiram or disulfiram-like drugs;
  4. Subjects with prosthetic cardiac valves, vascular grafts, pacers, or other non-removable vascular foreign body, with the exception of coronary stents and peripheral stents;
  5. Subjects with the presence of a deep-seated intravascular source of infection (eg, endocarditis [as evidenced by vegetations on an echocardiogram or clinical suspicion] or septic thrombosis);
  6. Subjects with bacteremia with documented microbiological evidence of another source of infection (eg, osteomyelitis, pneumonia, skin infection, urinary tract infection, joint infection, or abdominal infection) known to be due to the same organism cultured from the blood;
  7. Subjects with polymicrobial CRBSI/CLABSI caused by pathogens that would require multiple antibiotics to be used for adequate lock therapy treatment. For example, a subject with methicillin-resistant Staphylococcus aureus and Escherichia coli requiring treatment with vancomycin and meropenem would be excluded from the study. A subject with S. aureus and Staphylococcus epidermidis, where both are identified as pathogens and where both could be treated with vancomycin, would be eligible;
  8. Subjects with the presence of a tunnel or catheter exit site infection or an infusion port pocket abscess as manifested by purulence at the exit site, or inflammation with erythema, or induration of greater than 1 cm in diameter;
  9. Subjects who have been previously randomized into the present study;
  10. Subjects who are pregnant or lactating;
  11. Subjects with proven or suspected persistent bacteremia despite 72 hours of both systemic antibiotic therapy and lock therapy to which the infecting organism is susceptible;
  12. Subjects with short-term CVCs indwelling less than 5 days;
  13. Subjects with a central line-related mycobacterial infection; or
  14. Subjects who, in the opinion of the Investigator, have a high probability of death within 3 months of randomization due to a disease process other than the CRBSI/CLABSI
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you up to $350 for your time and effort. You will receive $50 each for visits T1,T2. You will receive $50 for completing all three visits T3-T5. You will receive $100 for visit T6. You will receive $50 for visit T7, and $50 completing week 8 (TOC) or Early Termination. You may also be reimbursed for travel to the study site for visits.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 56 days. There will be up to 15 days of treatment, a follow up phone call at week 5 after treatment, and a clinic visit at week 8 after treatment.
Recruitment period
From Jan. 23, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Carlos Figueroa
Research Topic
Conditions:
  • Catheter-related Infections