PDF(Pubmed)
Abstract：
According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.
摘要：
根据临床指南,凝固酶阴性葡萄球菌(CoNS)引起的导管相关血流感染(CRBSI)的治疗包括拔除导管和抗生素治疗5~7天.然而,在低风险事件中，目前尚不清楚抗生素治疗是否必要.这项随机临床试验旨在确定在CoNS引起的低风险CRBSI发作中，不使用抗生素治疗是否与推荐的策略一样安全有效。为了这个目的,一个随机的，开放标签，多中心，非劣效性临床试验于2019年7月1日至2022年1月31日在西班牙14家医院进行.由CoNS引起的低风险CRBSI的患者在拔除导管后以1：1随机分配接受/不接受具有针对分离菌株的活性的肠胃外抗生素。主要终点是在随访90天内出现与菌血症或抗生素治疗相关的任何并发症。次要终点是持续性菌血症，脓毒性栓塞,直到微生物治愈，直到发烧消失的时间。EudraCT：2017-003612-39INF-BACT-2017。总共对741名患者进行了资格评估。其中,研究中包括27人；15人（55.6％）被随机分配到干预组（非抗生素给药），12人（44.4％）被随机分配到对照组（根据标准实践进行抗生素治疗）。主要终点发生在干预组15例患者中的1例（化脓性血栓性静脉炎），对照组无患者。干预组微生物治愈的中位时间为3天（IQR1-3），对照组为1.25天（IQR0.5-2.62），而两组患者直到发热消退的中位时间为0天。由于招募的患者数量不足，该研究被终止。这些结果似乎表明，由CoNS引起的低风险CRBSI可以在拔除导管后无需抗生素治疗的情况下进行管理；疗效和安全性不受影响。
