一项前瞻性试点临床研究显示庆大霉素- edta - na2中心静脉导管锁定液具有良好的无毒抗生物膜活性。

IF 4.8 2区医学 Q1 INFECTIOUS DISEASES

International Journal of Infectious Diseases Pub Date : 2025-05-12 DOI:10.1016/j.ijid.2025.107933

David Lebeaux , Bérénice Souhail , Tan-Phuc Bui-Van , Lénaig Le-Fouler , Matthieu Lafaurie , Raphael Lepeule , Etienne Canoui , Victoire de Lastours , Antoine Froissart , Damien Blez , Christophe Beloin , Jean-Marc Ghigo , Fabrice Pirot , Carole Dhelens , Sandrine Fernandes-Pellerin

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引用次数: 0

摘要

目的：长期静脉导管相关血流感染（ltivc相关BSI）的治疗通常需要拔除导管或使用导管内锁进行保守治疗，成功率为50-60%。我们之前证明了庆大霉素和EDTA-Na2联合使用对细菌生物膜的协同作用。我们进行了一项1/2期临床试验，以评估genta-EDTA-Na2锁对ltivc相关BSI保守治疗的耐受性和有效性。方法：前瞻性研究纳入由庆大霉素敏感凝固酶阴性葡萄球菌、肠杆菌或铜绿假单胞菌引起的单菌性无并发症ltivc相关BSI的成年患者。主要目的：通过评估治疗结束后30天（D40）临床和微生物治愈的频率，评估genta-EDTA-Na2锁在第40天（D40）的安全性和有效性。结果：纳入8例患者。7例患者获得完整随访，其中6例达到治愈标准。随访不完整的单个患者在D23时满足所有治愈标准。发生单一微生物失败（铜绿假单胞菌ltivc相关BSI复发）。两名患者经历了至少一次严重不良事件；没有一个归因于genta-EDTA-Na2锁。结论：Genta-EDTA-Na2可能是一种有前景的抗生物膜候选药物，值得在随机对照试验中进行研究。

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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.

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来源期刊

International Journal of Infectious Diseases 医学-传染病学

CiteScore

18.90

自引率

2.40%

发文量

1020

审稿时长

30 days

期刊介绍： International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.