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

This is an interventional treatment trial for Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection Read More

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).