Abstract:
Objectives: The treatment of long-term intravenous catheter-related bloodstream infections (LTIVC-related BSI) often requires catheter removal or a conservative treatment using intra-catheter locks, with a 50-60% success rate. We previously demonstrated the synergistic effect of a combination of gentamicin and EDTA-Na2 against bacterial biofilms. We performed a phase 1/2 clinical trial to assess the tolerance and efficacy of the genta-EDTA-Na2 locks for the conservative treatment of LTIVC-related BSI.
Methods: Prospective study including adult patients with a monomicrobial uncomplicated LTIVC-related BSI caused by a gentamicin-susceptible coagulase-negative staphylococci, Enterobacterales or Pseudomonas aeruginosa.
Primary objective: assess the safety and efficacy at Day 40 (D40) of genta-EDTA-Na2 locks by evaluating the frequency of clinical and microbiological cure 30 days after the end of treatment (D40).
Results: Eight patients were included. A complete follow-up was obtained for 7 patients, 6 of which met cure criteria. The single patient whose follow-up was incomplete 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.
Conclusion: Genta-EDTA-Na2 used as intra-catheter locks may be a promising anti-biofilm candidate to be studied in a randomized controlled trial.
Reference:Lebeaux D, Souhail B, Van TB, Fouler LL, Lafaurie M, Lepeule R, Canoui E, de Lastours V, Froissart A, Blez D, Beloin C, Ghigo JM, Pirot F, Dhelens C, Fernandes-Pellerin S. A Prospective Pilot Clinical Study reveals a promising non-toxic anti-biofilm activity of Gentamicin-EDTA-Na2 Central Venous Catheter Lock Solution. Int J Infect Dis. 2025 May 12:107933. doi: 10.1016/j.ijid.2025.107933. Epub ahead of print. PMID: 40368083.