Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA

NCT ID: NCT04789928

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2024-03-01

Brief Summary

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.

Conditions

Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gentamicins-EDTA

Intervention Type: DRUG

Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics.

Interventions

Gentamicins-EDTA

Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics.

Intervention Type: DRUG

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Lebeaux

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges Pompidou AP-HP

Locations

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

HEGP

Paris, , France

Hôpital Henri Mondor

Paris, , France

Hôpital Saint-Louis

Paris, Île-de-France Region, France

Hôpital Cochin

Paris, Île-de-France Region, France

Hôpital Beaujon

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

2017-003

Identifier Type: -

Identifier Source: org_study_id