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Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI

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ClinicalTrials.gov Identifier: NCT02901717
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Leonard-Meron Biosciences, Inc.

Brief Summary:

This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution.

Approximately 700 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:

  • MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or
  • Control Arm: Antibiotic lock (±heparin) + SOC IV antibiotics. The antibiotic lock (ALT) should be comprised of the best available therapy at the sites based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines.

Condition or disease Intervention/treatment Phase
Catheter-related Infections Drug: Mino-Lok Drug: Antibiotic lock Phase 3

Detailed Description:

This is a Phase 3, multi-center, randomized, double-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution.

Mino-Lok Therapy is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion.

Approximately 700 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms:

  • MLT Arm: MLT + SOC intravenous (IV) antibiotic therapy; or
  • Control Arm (subjects randomized to the Control Arm will receive treatment based on the type and virulence of the infecting organism as documented by the Investigator prior to randomization): The antibiotic lock should be comprised of the best available therapy at the sites. Prior to randomization, the Investigator at each site will determine the antibiotic used in the lock, the dose, the dwell time, and the number of days of administration (minimum of 7 days) based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines. In the event that the subject is being treated with more than 1 systemic SOC IV antibiotic, the Investigator will specify a single antibiotic that should be used for the antibiotic lock. It is acceptable for the SOC antibiotic lock to differ from the SOC IV antibiotics, as necessary per local SOC.

All infecting organism types are permitted (eg, S. aureus, S. epidermidis, Candida spp., Pseudomonas aeruginosa). Randomization will be stratified by type of CVC, presence of neutropenia, and by virulence of the infecting organism.

The primary endpoint is the proportion of subjects in the ITT Population who have Overall Success at TOC (Week 8). Success is defined as any subject who demonstrates eradication of the pathogen, stabilization or improvement in signs and symptoms of the infection, catheter salvage, AND survival at termination of the study. Analysis for the primary endpoint will compare the overall success rate between the MLT Arm and the Control Arm.

Note: Patients who have had their catheters removed and replaced due to a CLABSI/CRBSI may be eligible for entry into the observation arm.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Standard of Care
Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection.
Drug: Antibiotic lock
Standard of Care antibiotics appropriate for the infecting organism with an antibiotic lock solution using the same standard of care antibiotic delivered systemically. The antibiotic lock arm may include subjects with S. aureus, including methicillin-resistant S. aureus, vancomycin intermediate S. aureus, or vancomycin-resistant S. aureus; vancomycin resistant enterococci; Candida, Pseudomonas; other Gram negative organisms; or other organisms deemed to be of high virulence per the Investigator. The standard of care antibiotic will be determined by the investigator at the start of treatment.
Other Name: Standard of Care antibiotics with antibiotic lock

Experimental: Mino-Lok Therapy (MLT)
Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
Drug: Mino-Lok
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter.
Other Name: Standard of care antibiotics + Mino-Lok

No Intervention: Observation arm
Patients who have had their catheters removed and replaced due to CLABSI/CRBSI will be assessed for outcomes following a similar schedule as the treatment arms. This is a non-randomized arm for obtaining information only. This arm will only be used for experimental endpoints.



Primary Outcome Measures :
  1. Proportion of subjects deemed successfully treated at the end of the study period [ Time Frame: 8 weeks ]
    Success is defined as any subject who demonstrates eradication of the pathogen, stabilization or improvement in signs and symptoms of the infection, catheter salvage, AND survival at termination of the study.


Secondary Outcome Measures :
  1. Proportion of subjects with a response of Clinical Cure at End of Treatment. [ Time Frame: 8 weeks ]
    Clinical Cure is defined as the absence of baseline CRBSI/CLABSI signs/symptoms or, in the Investigator's opinion, improvement of signs/symptoms such that no additional therapy is necessary.

  2. Proportion of subjects in the MITT and CE Populations with a response of microbiological eradication. [ Time Frame: 8 weeks ]
    Microbiological Eradication is the demonstration that the bacterial pathogen(s) found at baseline is absent with repeat blood culture.

  3. All-cause mortality [ Time Frame: 14 Days ]
    Death within 14 days of randomization

  4. All-cause mortality [ Time Frame: 28 Days ]
    Death within 28 days of randomization

  5. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 8 Weeks ]
    Safety and tolerability profile of subjects as assessed by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. A recognized single pathogen cultured from 1 or more blood cultures; OR
    2. 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);
  3. 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.
  4. 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;
  5. 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) ;
  6. 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;
  7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901717


Contacts
Contact: Alan Lader, Ph.D. 908-967-6677 alader@citiuspharma.com

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
St. Vincent Hospital Recruiting
Worcester, Massachusetts, United States, 01608
United States, Michigan
Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Health Systems Recruiting
Detroit, Michigan, United States, 48202
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma University Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Puerto Rico
VA Caribbean Healthcare System Recruiting
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Leonard-Meron Biosciences, Inc.

Responsible Party: Leonard-Meron Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02901717     History of Changes
Other Study ID Numbers: MDA-2013-0039
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Catheter-Related Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents