Catheter-related InfectionsPhase 3NCT02901717
Mino-Lok Therapy (MLT) for the Treatment of CRBSI/CLABSI
A Phase 3 study testing Mino-Lok and Antibiotic lock in people with Catheter-related Infections, run by Leonard-Meron Biosciences, Inc. at 22 sites in 2 countries.
Trial 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 as an adjuctive therapy for the treatment of catheter-related or central line associated… 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 and Antibiotic lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 13 Feb 2018to Mar 2023
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject or a legally authorized representative must provide a signed informed consent form;
- Male or female at least 12 years of age;
- Subject must 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 (greater than or equal to 38.0 degrees C), chills, or hypotension (systolic blood pressure less than 90 mmHg); NOTE: When possible, it is recommended to collect from both the CVC and peripheral venipuncture.
- 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 at least 5 days;
Show all 20Show fewer
- A bloodstream infection 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 or CLABSI;
- NOTE: Subjects may be enrolled and randomized while awaiting results of standard blood cultures from the local laboratory:
- If an organism has been identified from blood specimen testing using an FDA-cleared rapid diagnostic test (eg, T2MR®); or
- If a positive blood culture specimen shows an organism by 1 of the following:
- Gram stain; or An FDA-cleared molecular rapid diagnostic test (eg, FilmArray® BCID or Verigene®); If the pending blood culture does not confirm a qualifying organism by standard methods and an isolate is not available for testing at the central laboratory, the subject will be withdrawn from study drug treatment and managed at the Investigator's discretion.
- NOTE: Subjects with a positive blood culture identified up to 120 hours prior to enrollment and in whom the baseline pathogen is still available for analysis at the central laboratory may be considered on a case by-case basis with prior approval from the Medical Monitor.
- Subjects for whom, in the Investigator's opinion, catheter retention for the duration of the study (6 weeks) is reasonable or required;
- Female subjects of childbearing potential must have a negative urine and/or serum pregnancy test within 5 days prior to randomization;
- NOTE: The following are considered women who are NOT of childbearing potential:
- Postmenopausal (defined as no menses for at least 12 consecutive months); or
- Documented to be surgically sterile;
- Female subjects of childbearing potential and male subjects who are sexually active must agree to use a highly effective method of contraception from the time of informed consent until 30 days post dose; NOTE: Highly effective methods of contraception include hormonal contraceptives, intrauterine device, double-barrier method, partner sterility, or abstinence.
- 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; and
- Subject must be willing to comply with all study procedures, whether inpatient or outpatient, for the duration of the study.
Who cannot join
- Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
- Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
- Subjects taking disulfiram at the time of randomization or who are expected to take disulfiram at any time during treatment with study drug;
- Subjects with prosthetic cardiac valves, vascular grafts, pacers, automatic implantable cardioverter-defibrillator, or other non-removable vascular foreign body, with the exception of coronary stents and peripheral stents;
- 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);
- 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;
Show all 14Show fewer
- 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; NOTE: If more than 1 organism is isolated, the Investigator should decide which of the organisms are pathogens and require therapy. Isolates of all organisms should be sent to the central laboratory. In the event that the subject is being treated with more than 1 systemic standard of care (SOC) anti-infective, 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 anti infectives, as necessary per local SOC.
- 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 at least 1 cm in diameter;
- Subjects who have been previously randomized into the present study;
- Subjects who are pregnant or breastfeeding;
- Subjects with proven or suspected persistent bacteremia or fungemia despite 72 hours of both systemic anti-infective therapy and lock therapy to which the infecting organism is susceptible;
- Subjects with short-term CVCs indwelling at least 5 days;
- Subjects with a central line-related mycobacterial infection or fungi other than Candida; or
- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States19 sites, 15 recruiting
- Suspended
Anne Arundel Medical Center
Annapolis, Maryland, 21401
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28203
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Henry Ford Health Systems
Detroit, Michigan, 48202
- Recruiting
University of Florida Shands Hospital
Gainesville, Florida, 32608
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
- Recruiting
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Indiana Blood and Marrow Institute
Indianapolis, Indiana, 46237
- Suspended
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Recruiting
Saint Michael's Medical Center
Newark, New Jersey, 07102
- Recruiting
AMG Oncology
Park Ridge, Illinois, 60068
- Recruiting
VA Sierra Nevada Health Care Systems
Reno, Nevada, 89502
- Recruiting
Salem VA Medical Center
Salem, Virginia, 24153
- Suspended
Seattle Children's Hospital
Seattle, Washington, 98105
- Suspended
William Beaumont Hospital
Troy, Michigan, 48083
- Recruiting
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Recruiting
Ascension Via Christi Hospital
Wichita, Kansas, 67214
Puerto Rico3 sites, 3 recruiting
- Recruiting
Manati Medical Center
Manati
- Recruiting
Ponce Research Institute
Ponce
- Recruiting
VA Caribbean Healthcare System
San Juan, PR, 00921
About this study
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
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 as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
Approximately 144 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: Mino-Lok therapy; or
- Control Arm: Antibiotic lock (±heparin). 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.
Read the 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 144 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 for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
A catheter failure event is ANY of the following:
- All-cause mortality at TOC (Week 6). The event time is the day of death;
- Catheter removal for any infection-related reasons (including worsening of symptoms or failure to eradicate the infection). The event time is the day the catheter is removed;
- Inability to administer study drug. The event time is the day the Investigator determines the catheter is no longer functional;
- Worsening of systemic signs and symptoms of infection that result in change in systemic anti infective treatment. Note that changes in treatment based on susceptibility data will be permitted. The event time is the day the treatment is changed;
- Demonstration that the baseline pathogen is not eradicated from the blood culture collected within 72 hours following randomization despite 72 hours of antibiotic therapy to which the infecting organism is susceptible. Best clinical practice and subject safety may dictate changes in treatment prior to 72 hours. The event time is the day of the positive culture;
- Demonstration that the baseline pathogen has recurred based on blood culture results by Week 6 of the study. The event time is the day of the positive blood culture documenting the recurrence. If a subject does not show any signs and symptoms of an infection and there is a negative blood culture prior to Week 6, then a blood culture does not have to be performed at Week 6. Subjects whose catheter was removed for reasons not related to the baseline infection also do not need to have a blood culture at Week 6; or
- Demonstration that the baseline pathogen is part of a newly diagnosed deep-seated infection by Week 6 of the study. The event time is the day of the new diagnosis.
Removal of the CVC prior to TOC because the catheter is no longer needed will not be considered a catheter failure and these subjects will be censored at the time of catheter removal.
- Conditions
- Catheter-related Infections
- Being tested
- Mino-Lok, Antibiotic lock
- 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-LokDrug
Also called Standard of care antibiotics + Mino-Lok
Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter.
Antibiotic lockDrug
Also called Standard of Care antibiotics with 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection. Receives: Drug: Antibiotic lock |
| Mino-Lok Therapy (MLT) | Experimental | Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol. Receives: Drug: Mino-Lok |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to a catheter failure event.
The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Measured: 6 weeks
Secondary outcomes (6)
Proportion of subjects with overall success in the MITT and CE populations.
Overall success is defined as no catheter failure events by TOC (week 6).
Measured: 6 weeks
Time to catheter failure in the MITT and CE Populations.
The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6).
Measured: 6 weeks
Microbiological eradication
Proportion of subjects with Microbiological Eradication at TOC (Week 6) in the MITT and CE Populations.
Measured: 6 weeks
Clinical Cure
Proportion of subjects with Clinical Cure at TOC (Week 6) in the MITT and CE Populations.
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.
Measured: 6 Weeks
All-cause mortality
Death within 6 weeks of randomization
Measured: 6 weeks
Safety and Tolorability
Safety and tolerability profile as assessed by adverse events, serious adverse events (SAEs), vital signs, clinical laboratory evaluations, and physical examinations.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start13 Feb 2018
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
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
- NCT02901717
- Sponsor's protocol ID
- MDA-2013-0039
- Status last verified
- Jul 2021
- First submitted
- 31 Aug 2016
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02901717
- Acronym / sponsor ID
- MDA-2013-0039
- Conditions
- Catheter-related Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Leonard-Meron Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 15 Sep 2016 (estimated)
- 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 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 as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI).
Approximately 144 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: Mino-Lok therapy; or
- Control Arm: Antibiotic lock (±heparin). 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.
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 144 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 for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
A catheter failure event is ANY of the following:
- All-cause mortality at TOC (Week 6). The event time is the day of death;
- Catheter removal for any infection-related reasons (including worsening of symptoms or failure to eradicate the infection). The event time is the day the catheter is removed;
- Inability to administer study drug. The event time is the day the Investigator determines the catheter is no longer functional;
- Worsening of systemic signs and symptoms of infection that result in change in systemic anti infective treatment. Note that changes in treatment based on susceptibility data will be permitted. The event time is the day the treatment is changed;
- Demonstration that the baseline pathogen is not eradicated from the blood culture collected within 72 hours following randomization despite 72 hours of antibiotic therapy to which the infecting organism is susceptible. Best clinical practice and subject safety may dictate changes in treatment prior to 72 hours. The event time is the day of the positive culture;
- Demonstration that the baseline pathogen has recurred based on blood culture results by Week 6 of the study. The event time is the day of the positive blood culture documenting the recurrence. If a subject does not show any signs and symptoms of an infection and there is a negative blood culture prior to Week 6, then a blood culture does not have to be performed at Week 6. Subjects whose catheter was removed for reasons not related to the baseline infection also do not need to have a blood culture at Week 6; or
- Demonstration that the baseline pathogen is part of a newly diagnosed deep-seated infection by Week 6 of the study. The event time is the day of the new diagnosis.
Removal of the CVC prior to TOC because the catheter is no longer needed will not be considered a catheter failure and these subjects will be censored at the time of catheter removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Antibiotic lockAntibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection. |
| Mino-Lok Therapy (MLT) | Experimental | Drug: Mino-LokStandard of care plus MLT. MLT contains minocycline with EDTA and ethanol. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Subject or a legally authorized representative must provide a signed informed consent form;
- Male or female at least 12 years of age;
- Subject must have a bloodstream infection with no other apparent source other than the CVC that meets one of the following criteria:
- 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 at least 5 days;
- A bloodstream infection 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 or CLABSI;
Key exclusion criteria (14 listed)
- Subjects with hypersensitivity or allergy to tetracycline antibiotics or edetate disodium;
- Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
- Subjects taking disulfiram at the time of randomization or who are expected to take disulfiram at any time during treatment with study drug;
- Subjects with prosthetic cardiac valves, vascular grafts, pacers, automatic implantable cardioverter-defibrillator, or other non-removable vascular foreign body, with the exception of coronary stents and peripheral stents;
- 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);
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-LokAlso: Standard of care antibiotics + Mino-LokStandard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. | Drug | Mino-Lok Therapy (MLT) |
| Antibiotic lockAlso: Standard of Care antibiotics with antibiotic lockStandard 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. | Drug | Standard of Care |
Primary outcome
Time to a catheter failure event.
Time frame: 6 weeks
The time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
6 secondary outcomes
Proportion of subjects with overall success in the MITT and CE populations.
Time frame: 6 weeks
Time to catheter failure in the MITT and CE Populations.
Time frame: 6 weeks
Microbiological eradication
Time frame: 6 weeks
Clinical Cure
Time frame: 6 Weeks
All-cause mortality
Time frame: 6 weeks
Safety and Tolorability
Time frame: 6 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Catheter-related Infections
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
RecruitingPhase 4
Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
Venous Thromboembolism, Cancer
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.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mino-Lok and Antibiotic lock in people with Catheter-related Infections, run by Leonard-Meron Biosciences, Inc. at 22 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 20 inclusion and 14 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, clinops@citiuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to a catheter failure event. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
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 19 Apr 2022.