From the Medical University, University Multiprofile Hospital for Active Treatment "Sveti Georgi," Plovdiv, Clinic of Pediatric and Genetic Diseases, Plovdiv, Bulgaria.
Amtel Hospital First Clinical LLC, Department of Pediatrics, Tbilisi, Georgia.
Pediatr Infect Dis J. 2021 Jun 1;40(6):e222-e229. doi: 10.1097/INF.0000000000003077.
The advanced-generation, broad-spectrum, intravenous (IV) cephalosporin, ceftobiprole, is an effective and well-tolerated treatment for adults with hospital-acquired pneumonia (HAP) or community-acquired pneumonia (CAP), but its effects in pediatric patients have not been established.
In this multicenter, investigator-blinded, active-controlled, phase 3 study, patients 3 months to <18 years old with HAP or CAP requiring hospitalization were randomized (2:1) to ceftobiprole versus standard-of-care (SoC) IV cephalosporin treatments (ceftazidime or ceftriaxone), with or without vancomycin. After at least 3 days' IV treatment, patients demonstrating clinical improvement could be switched to an oral antibiotic, to complete a minimum of 7 days' treatment.
Overall, 138 patients were randomized to ceftobiprole (n = 94) or a SoC cephalosporin (n = 44). Median time to oral switch was 6.0 days in the ceftobiprole group and 8.0 days in the SoC cephalosporin group. While on IV therapy, adverse events and treatment-related adverse events were reported by 20.2% and 8.5% of ceftobiprole-treated patients and 18.2% and 0% of SoC cephalosporin-treated patients. Early clinical response rates at day 4 in the intention-to-treat population were 95.7% and 93.2% (between-group difference, 2.6%; 95% confidence interval, -5.5% to 14.7%) in the ceftobiprole and comparator groups, and clinical cure rates at the test-of-cure visit were 90.4% and 97.7% (between-group difference, -7.3%; 95% confidence interval, -15.7% to 3.6%), respectively.
Ceftobiprole was well tolerated and, in this small phase 3 study, demonstrated similar efficacy to SoC cephalosporins in pediatric patients with HAP or CAP requiring hospitalization.
新一代广谱静脉注射（IV）头孢菌素头孢托罗是一种有效且耐受性良好的治疗药物，适用于患有医院获得性肺炎（HAP）或社区获得性肺炎（CAP）的成年人，但尚未在儿科患者中确立其疗效。
在这项多中心、研究者设盲、活性对照、3 期研究中，3 个月至<18 岁、需要住院治疗的 HAP 或 CAP 患者按 2:1 的比例随机分配至头孢托罗组（n=94）或标准治疗（SoC）IV 头孢菌素组（n=44），其中头孢托罗组加用或不加用万古霉素。接受至少 3 天的 IV 治疗后，如果患者临床症状改善，可转换为口服抗生素，完成至少 7 天的治疗。
共有 138 例患者被随机分配至头孢托罗组（n=94）或 SoC 头孢菌素组（n=44）。头孢托罗组达到口服转换的中位时间为 6.0 天，SoC 头孢菌素组为 8.0 天。在接受 IV 治疗期间，头孢托罗组分别有 20.2%和 8.5%的患者报告发生不良事件和治疗相关不良事件，SoC 头孢菌素组分别有 18.2%和 0%的患者报告发生上述事件。意向治疗人群在第 4 天的早期临床应答率分别为头孢托罗组 95.7%和对照组 93.2%（组间差异为 2.6%；95%置信区间为-5.5%至 14.7%），在治愈测试访视时的临床治愈率分别为头孢托罗组 90.4%和对照组 97.7%（组间差异为-7.3%；95%置信区间为-15.7%至 3.6%）。
头孢托罗具有良好的耐受性，在这项小型 3 期研究中，头孢托罗在需要住院治疗的 HAP 或 CAP 儿科患者中的疗效与 SoC 头孢菌素相当。
