Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT04789928
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.
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04789928
Study Brief:
Protocol Section:
NCT04789928