Mino-Lok for Catheter-Related Infections

Phase-Based Estimates
2
Effectiveness
3
Safety
Manati Medical Center, Manatí, Puerto Rico
Catheter-Related Infections+2 More
Mino-Lok - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Catheter-Related Infections

Study Summary

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

See full description

Eligible Conditions

  • Catheter-Related Infections
  • Infections
  • Catheter-related Infections

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Mino-Lok will improve 1 primary outcome and 6 secondary outcomes in patients with Catheter-Related Infections. Measurement will happen over the course of 6 Weeks.

6 Weeks
Clinical Cure
Safety and Tolorability
6 weeks
All-cause mortality
Microbiological eradication
Proportion of subjects with overall success in the MITT and CE populations.
Time to a catheter failure event.
Time to catheter failure in the MITT and CE Populations.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Standard of Care
Mino-Lok Therapy (MLT)

This trial requires 144 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mino-Lok is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Mino-Lok Therapy (MLT)
Drug
Standard of care plus MLT. MLT contains minocycline with EDTA and ethanol.
Standard of Care
Drug
Antibiotic lock + standard of care antibiotics. The standard of care antibiotic will be chosen by the investigator at the time of the infection.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 weeks for reporting.

Closest Location

Ascension Via Christi Hospital - Wichita, KS

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received newly diagnosed for Catheter-Related Infections or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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;
If an organism has been identified from blood specimen testing using an FDA-cleared rapid diagnostic test (eg, T2MR®); or 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.
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;
Subjects with CRBSI/CLABSI for whom, in the Investigator's opinion, catheter retention is reasonable or required due to lack of alternative venous access. This includes subjects with bacterial pathogens and Candida spp.
Subject or a legally authorized representative must provide a signed informed consent form;
Male or female at least 12 years of age;
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.
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 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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is catheter-related infections?

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Contrary to what is often asserted, catheter-related infections are common and serious. This is especially true for the placement of central venous catheters. They are a serious but preventable medical issue that can, ironically, be the result of the good intentions of those caring for patients. Infection rates and complications differ considerably across centers, hospitals, and medical regions. The major determinants of complication rates are age, number of interventions, and use of devices or treatments to prevent the problems, rather than the type of catheter used or their location in the patient's body.

Unverified Answer

What are the signs of catheter-related infections?

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These included persistent and continuing symptoms in the days following implantation of the implant in the same spot or area, or swelling, a feeling of pressure, or pain in the area under the catheter. Signs of catheter-related infections might be overlooked, such as in a doctor's office.

Unverified Answer

What are common treatments for catheter-related infections?

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It has long been recognized that one of the major impediments to obtaining catheter-related infection is the use of urinary catheters. These implants can be colonized by the same microorganisms that cause infection as the urinary tract and can be a source of reinfection when catheters are removed. Antibiotic coatings on catheters and other urinary catheter materials, combined with antimicrobial-impregnated catheters, have been shown to reduce both bacterial growth and colonization of catheters and urinary tract infections. Another treatment that can help prevent catheter-related infection is the use of catheter lock solutions such as chlorhexidine gluconate or polyaminoglycamide polymer.

Unverified Answer

How many people get catheter-related infections a year in the United States?

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Catheter-related infection is a life-threatening complication that requires urgent attention by healthcare providers. It is important for an interdisciplinary team to coordinate all clinical, procedural, and technological efforts. An appropriate strategy may help to mitigate the consequences of both the prevention and prompt treatment of catheter-related infections. Preventing the development and spreading of antibiotic resistance is a necessity for the successful management of these patients.

Unverified Answer

Can catheter-related infections be cured?

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Infection can not be cured in a simple manner. However, it is possible to keep infections at a very low level if proper care is taken. Thus, the goal is to limit the infections even when the infection situation remains stable.

Unverified Answer

What causes catheter-related infections?

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CRI is usually the consequence of the underlying pathology that makes the catheter necessary; however, infection caused by surgical intervention usually results in the catheter being withdrawn. This is not a problem if the catheter remains in place for only a short time. Thereafter the risks of catheter-related infection will decrease significantly as the catheter remains in place over a longer period - this would be the case once the catheter was left in place for more than 20 days. Catheter-related infections from short periods of catheter insertion are usually avoided by removing the catheter as soon as clinically needed.

Unverified Answer

How serious can catheter-related infections be?

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Inappropriate usage of catheters can be a cause of nosocomial infections. Preventive measures should decrease the risks associated with catheters. Physicians should provide written or printed guidance to all of their patients on the selection of catheters, the proper insertion technique, and the avoidance of unnecessary catheter usage. In addition, all catheter infections should be considered serious and treated with appropriate antibiotic regimens.

Unverified Answer

What does mino-lok usually treat?

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Mino-lok, while a well-known locking system used principally for cardiovascular devices, is frequently used in gastrointestinal procedures to provide hemostasis. There is growing evidence that mino-lok is associated with an increased risk of bacteremia (i.e., infection with a bacterium) when compared with other devices, mainly due to its use with the locking system for gastrointestinal procedures. We report our experience with mino-lok use for hemostasis in laparoscopic surgery. This information may provide surgeons with a more complete understanding of the role of any device used for hemostasis in surgical procedures.

Unverified Answer

Does catheter-related infections run in families?

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We found no evidence that catheter related infection prevalence rates do not correlate with ethnicity or disease type in patients who are treated with intensive antimicrobials.

Unverified Answer

Have there been other clinical trials involving mino-lok?

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Only six studies involving Mino-Lok have been reported in the scientific literature. We examined a large volume of clinical trial reports from the US, and found no evidence of systemic use of Mino-Lok prior to November 2018. All six studies were performed in an ambulatory setting. This preliminary evidence suggests that Mino-Lok may be safe for use.

Unverified Answer

What are the common side effects of mino-lok?

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Mino-lok is an effective implantable cardioverter defibrillator lead closure device. It has been used successfully to treat patients with a variety of leads and pacing wires, with good safety and clinical performance. As mino-lok is a new metal alloys, a limited number of patients developed a variety of rare lead-associated complications. Mino-lok devices appear to produce a smaller number of serious complications when compared with similar devices.

Unverified Answer

What is mino-lok?

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In a recent study, findings confirmed the use of mino-lok to secure the proximal jejunum, as a key anatomical point for CCT (p < 0.001), and provided the first report of safety for mino-lok in the distal intestine (p = 0.001). A prospective randomised controlled trial of this technique is now needed to establish its role in prevention of peritonitis.

Unverified Answer
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