A Prospective Pilot Clinical Study reveals a promising non-toxic anti-biofilm activity of gentamicin-EDTA-Na₂ Central Venous Catheter Lock Solution.

OBJECTIVES

The treatment of long-term intravenous catheter-related bloodstream infections (LTIVC-related BSI) often requires catheter removal or conservative treatment using intra-catheter locks, with a 50-60% success rate. We previously demonstrated the synergistic effect of a combination of gentamicin and ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) against bacterial biofilms. We conducted a phase 1/2 clinical trial to assess the tolerance and efficacy of genta-EDTA-Na2 locks for the conservative treatment of LTIVC-related BSI.

METHODS

Prospective study including adult patients with monomicrobial, uncomplicated LTIVC-related BSI caused by gentamicin-susceptible coagulase-negative staphylococci, Enterobacterales, or Pseudomonas aeruginosa.

PRIMARY

OBJECTIVE

assess the safety and efficacy at genta-EDTA-Na2 locks at day 40 (D40) by evaluating the frequency of clinical and microbiological cure 30 days after the end of treatment (D40).

RESULTS

Eight patients were included. Complete follow-up was obtained for seven patients, six of whom met the criteria for cure. The single patient with incomplete follow-up met all criteria for cure at D23. A single microbiological failure occurred (relapse of P. aeruginosa LTIVC-related BSI). Two patients experienced at least one serious adverse event; none were attributed to the genta-EDTA-Na2 locks.

CONCLUSIONS

Genta-EDTA-Na2, used as intra-catheter locks, may be a promising anti-biofilm candidate for evaluation in a randomized controlled trial.