Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA (CATH-GE)

June 4, 2024 updated by: Institut Pasteur

Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections

Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Créteil, France
        • Centre Hospitalier Intercommunal de Creteil
      • Paris, France
        • HEGP
      • Paris, France
        • Hopital Henri Mondor
    • Ile De France
      • Paris, Ile De France, France, 75010
        • Hopital Saint-Louis
      • Paris, Ile De France, France, 75014
        • Hôpital Cochin
      • Paris, Ile De France, France, 92000
        • Hôpital Beaujon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient (≥18 year-old);
  • LTIVC in place (TIVAP or single-line tunnelled catheter);
  • LTIVC is functional (it is possible to inject an infusate, but also to draw blood from the catheter);
  • LTIVC-related bloodstream infection defined by a positive qualitative paired blood culture with a differential time to positivity ≥ 2 hours (meaning that the culture of the blood drawn from the catheter is positive at least 2 hours before the culture of the blood drawn from a peripheral vein);
  • Mono microbial infection caused by coagulase-negative staphylococci, Enterobacteriaceae or Pseudomonas aeruginosa;
  • Bacterial strain is susceptible toward gentamicin;
  • Life expectancy ≥ 3 months;
  • Physician in charge of the patient agrees to perform a conservative treatment;
  • Calculated creatinine clearance ≥ 30 mL/min;
  • Patient's informed and written consent is collected.
  • For women of reproductive age: available beta-HCG dosage (with negative result) < 72h.

Non-inclusion criteria:

A patient should not be included if he presents any of the following criteria:

  • Presence of any systemic complication (sepsis or septic shock, as defined by the sepsis-3 guidelines), or local complications (tunnel or port-pocket infection, thrombophlebitis, endocarditis, bone and joint infections related to the LTIVC-related BSI);
  • Allergy toward aminoglycosides
  • PICC-line or hemodialysis tunnelled catheter; LTIVC removal is planned within the following 3 months or LTIVC is not required for the management of the patient's underlying medical condition anymore;
  • Diagnosis of LTIVC-related bloodstream infection has been made more than 3 days ago (e.g. >72 hours between the day the first blood culture drawn from the LTIVC is positive and screening visit);
  • Systemic treatment of LTIVC-related bloodstream infection includes aminoglycosides (defined as a recent (<36 hours before screening visit) or ongoing systemic injection of aminoglycosides);
  • Low blood ionized calcium level (<1,15 μmol/L) before injecting the first dose of genta-EDTA-Na2 lock;
  • Presence of prosthetic heart valve, pacemaker or implantable defibrillator;
  • The LTIVC has been inserted less than 14 days ago;
  • Available Count blood cells < 72h with severe neutropenia (<500 polymorphonuclear cells/mm3);
  • Subject with infection caused by Staphylococcus Aureus orCandida-spp;
  • The patient is not expected to remain in hospital for at least 7 days after inclusion.
  • The administration of the lock according to the protocol (24 hours/day for 48 hours and then at least 12 hours/24 hours for 5 to 8 days) is not possible.
  • Decision by the referring physician to prescribe a preventive lock following curative Gentamicin-EDTA treatment (secondary prevention), between the end of treatment (D6/D9) and the D40 follow-up visit.
  • Previous inclusion in a study or another therapeutic protocol requiring continuous use of the catheter
  • Pregnant and breastfeeding woman;
  • Protected adult subject.
  • Inability to perform a blood peripheral venous sampling

Exclusion criteria

A patient should be excluded if he presents any of the following criteria:

  • Presence of local or systemic complication seen on venous ultrasound performed between D2 and D5 or transthoracic echocardiography performed between Day 2 and Day 7 (D2-D7);
  • GFR < 30 ml/min (between D0 and D6/9).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with uncomplicated LTIVC-related BSI and eligible
Patients included in this study will receive daily injection of genta-EDTA-Na2 lock associated with systemic antibiotics.
Drug: Gentamicins-EDTA
Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The clinical efficacy is assessed by the frequency of clinical and microbial cure after 30 days of follow-up after the end of treatment (D40)
Time Frame: 30 days of follow-up after the end of treatment (D40)
Resolution of clinical signs at the end of treatment (D6 if the patient already received 72h of a previous active lock before inclusion or D9 if he received a complete 10-day course of genta-EDTA-Na2 locks) and 30 days after completion of therapy (D40)
30 days of follow-up after the end of treatment (D40)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The long-term clinical efficacy is assessed by the frequency of microbial cure after 90 days of follow-up after the end of treatment.
Time Frame: after 90 days of follow-up after the end of treatment (D100)
Absence of microbial relapse (BSI with the same microbial pathogen, i.e. same species and same antibiotic susceptibility pattern) between D6-D9 and D100;
after 90 days of follow-up after the end of treatment (D100)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Pasteur

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Lebeaux, Hopital Européen Georges Pompidou AP-HP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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