Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Pasteur
• Treatments: Gentamicins

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.

Exclusion Criteria:

• Presence of any systemic complication (sepsis or septic shock), 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 the screening visit);

• Systemic treatment of LTIVC-related bloodstream infection includes aminoglycosides (defined as a recent (<36 hours) or ongoing systemic injection of aminoglycosides)

• Low blood ionized calcium level (<1,15 mmol/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 or Candida 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.

• Previous inclusion in a study or another therapeutic protocol requiring continuous use of the catheter

• Inability to perform a blood peripheral venous sampling

• Pregnant and breastfeeding women,

• Protected adults subject