Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy
 (MLT) in Combination with Systemic Antibiotics in the Treatment of Central Line Associated
 Bloodstream Infection. Mino-Lok may be made available for patients who otherwise do not
 qualify for the phase 3 clinical trial (NCT02901717 )
This is an Intermediate-Size Expanded Access, Open-Label Study for Use of Mino-Lok Therapy
 (MLT) in Combination with Systemic Antibiotics in the Treatment of Central Line Associated
 Bloodstream Infection.

 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.

 This is an expanded access program (EAP). This program is designed to provide access to
 Mino-Lok. A physician must decide whether the potential benefit outweighs the risk of
 receiving an investigational therapy.

 To learn more about this study, please refer to this study by its ClinicalTrials.gov
 identifier (NCT number): NCT02901717
Inclusion Criteria:

 1. Subject or a legally authorized representative must provide a signed informed consent
 form;

 2. The subject should be male or female at least 12 years of age. This product has not
 been studied in a younger pediatric population;

 3. Subject should have a bloodstream infection with no other apparent source other than
 the CVC that meets one of the following criteria:

 -  A recognized single pathogen cultured from 1 or more blood cultures; OR

 -  A common skin contaminant cultured from 2 or more blood cultures drawn on the
 same or consecutive calendar days from a subject with fever (>38.0 C), chills, or
 hypotension (systolic blood pressure <90 mmHg); Note that these criteria are
 based on the CDCs definition of CLABSI. Please consult the CDC website for
 guidance at https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_clabscurrent.pdf.

 4. Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or
 required;

 5. This product has not been studied in women who are pregnant or lactating. It's effect
 on sperm development has also not been studied. Please consider this with female
 patients that are pregnant or who plan to become pregnant, or female patients who are
 breastfeeding. Likewise, male patients should refrain from sperm donation for 90 days
 following exposure to MLT. NOTE: Highly effective methods of contraception include
 hormonal contraceptives, intrauterine device, double-barrier method, partner
 sterility, or abstinence are strongly recommended.

 Exclusion Criteria:

 Subjects who meet any of the following criteria should not be exposed to MLT:

 1. Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate
 disodium;

 2. Subjects taking disulfiram at the time of enrollment or who are expected to take
 disulfiram at any time during treatment with study drug;

 3. The benefit of MLT in subjects with prosthetic cardiac valves, vascular grafts,
 pacers, automatic implantable cardioverter-defibrillator, or other non-removable
 vascular foreign body should be evaluated prior to exposure. The Investigator should
 be confident that these are not the source of infection;

 4. The benefit of MLT in subjects with a deep-seated intravascular source of infection
 (eg, endocarditis [as evidenced by vegetations on an echocardiogram or clinical
 suspicion] or septic thrombosis) should be evaluated prior to exposure. The
 Investigator should be confident that these are not the source of infection.