- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789928
Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA (CATH-GE)
July 6, 2023 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
35
Phase
- 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
- Name: David Lebeaux
- Phone Number: +33 1 56 09 29 69
- Email: david.lebeaux@aphp.fr
Study Contact Backup
- Name: Sandrine Fernandes Pellerin
- Phone Number: +33145688179
- Email: cath-ge@pasteur.fr
Study Locations
-
-
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Créteil, France
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
-
Contact:
- Antoine Froissart
- Email: antoine.froissart@chicreteil.fr
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Paris, France
- Recruiting
- HEGP
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Contact:
- Damien Blez
- Email: damien.blez@aphp.fr
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Paris, France
- Recruiting
- Hopital Henri Mondor
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Contact:
- Raphaël Lepeule
- Phone Number: 01 49 81 28 31
- Email: raphael.lepeule@aphp.fr
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-
Ile De France
-
Paris, Ile De France, France, 75014
- Recruiting
- Hopital Cochin
-
Contact:
- Etienne Canoui
- Email: etienne.canoui@aphp.fr
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Paris, Ile De France, France, 75010
- Recruiting
- Hopital Saint-Louis
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Contact:
- Matthieu Lafaurie
- Email: matthieu.lafaurie@aphp.fr
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Paris, Ile De France, France, 92000
- Recruiting
- Hopital Beaujon
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Contact:
- Andréa De la Selle
- Email: andrea.delaselle@aphp.fr
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-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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;
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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
Investigators
- Principal Investigator: David Lebeaux, Hôpital 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)
January 5, 2021
Primary Completion (Estimated)
December 31, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 6, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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