Catheter-Related InfectionsMLKNCT04513821
Expanded Access: Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
A study testing Mino-Lok Therapy (MLT) in people with Catheter-Related Infections, run by Leonard-Meron Biosciences, Inc. at 30 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Mino-Lok Therapy (MLT)
- How many people
- Not given
- Where
- 30 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subject or a legally authorized representative must provide a signed informed consent form;
- The subject should be male or female at least 12 years of age. This product has not been studied in a younger pediatric population;
- 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.
- Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;
- 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.
Who cannot join
- Subjects who meet any of the following criteria should not be exposed to MLT:
- Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
- Subjects taking disulfiram at the time of enrollment or who are expected to take disulfiram at any time during treatment with study drug;
- 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;
- 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.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States27 sites
- Available
University of New Mexico
Albuquerque, New Mexico, 87106
- Available
Anne Arundel Medical Center
Annapolis, Maryland, 21401
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Available
Carolinas Medical Center
Charlotte, North Carolina, 28203
- Available
University of Cincinnati
Cincinnati, Ohio, 45219
- Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Available
Cleveland Clinic
Cleveland, Ohio, 44195
- Available
Harper University Hospital
Detroit, Michigan, 48201
- Available
Henry Ford Health Systems
Detroit, Michigan, 48202
- Available
University of Florida - Shands Hospital - Dialysis Center
Gainesville, Florida, 32608
- Available
East Carolina University
Greenville, North Carolina, 27858
- Available
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
- Available
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Available
Indiana Blood and Marrow Institute
Indianapolis, Indiana, 46237
- Available
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Available
Yale University School of Medicine
New Haven, Connecticut, 06510
- Available
Saint Michael's Medical Center
Newark, New Jersey, 07102
- Available
AMG Oncology
Park Ridge, Illinois, 60068
- Available
Lutheran Hospital
Park Ridge, Illinois, 60068
- Available
Phoenix VA Health Care System
Phoenix, Arizona, 85012
- Available
VA Sierra Nevada Health Care Systems
Reno, Nevada, 89502
- Available
Salem VA Medical Center
Salem, Virginia, 24153
- Available
Seattle Children's Hospital
Seattle, Washington, 98105
- Available
William Beaumont Hospital
Troy, Michigan, 48083
- Available
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Available
Ascension Via Christi Hospital
Wichita, Kansas, 67214
- Available
St. Vincent Hospital
Worcester, Massachusetts, 01608
Puerto Rico3 sites
- Available
Manati Medical Center
Manati
- Available
Ponce Research Institute
Ponce
- Available
VA Caribbean Healthcare System
San Juan, PR, 00921
About this study
Official title: CITI-100 EA - 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
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 )
Read the detailed description
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
- Conditions
- Catheter-Related Infections
- Being tested
- Mino-Lok Therapy (MLT)
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mino-Lok Therapy (MLT)Drug
Also called Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. Mino-Lok is made available through this expanded access protocol to patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717) Other Name: Standard of care antibiotics + Mino-Lok
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Leonard-Meron Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513821
- Sponsor's protocol ID
- CITI-100 EA
- Acronym
- MLK
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CITI-100 EA - 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
- ClinicalTrials.gov ID
- NCT04513821
- Acronym / sponsor ID
- MLK / CITI-100 EA
- Conditions
- Catheter-Related Infections
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Leonard-Meron Biosciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 )
Detailed description
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
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject or a legally authorized representative must provide a signed informed consent form;
- The subject should be male or female at least 12 years of age. This product has not been studied in a younger pediatric population;
- Subject should have a bloodstream infection with no other apparent source other than the CVC that meets one of the following criteria:
- Subjects for whom, in the Investigator's opinion, catheter retention is reasonable or required;
- 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.
Key exclusion criteria (5 listed)
- Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
- Subjects taking disulfiram at the time of enrollment or who are expected to take disulfiram at any time during treatment with study drug;
- 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;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mino-Lok Therapy (MLT)Also: Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. Mino-Lok is made available through this expanded access protocol to patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717) Other Name: Standard of care antibiotics + Mino-Lok | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mino-Lok Therapy (MLT) in people with Catheter-Related Infections, run by Leonard-Meron Biosciences, Inc. at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Lader, Ph.D (908-967-6677, expandedaccess@citiuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.