头孢洛林与头孢曲松治疗儿童社区获得性肺炎的随机前瞻性研究

A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone.

作者信息

Cannavino Christopher R, Nemeth Agnes, Korczowski Bartosz, Bradley John S, O'Neal Tanya, Jandourek Alena, Friedland H David, Kaplan Sheldon L

机构信息

From the *Division of Infectious Diseases, Department of Pediatrics, University of California at San Diego and Rady Children's Hospital, San Diego, California; †Faculty of Medicine, 2nd Department of Pediatrics, Semmelweis University, Budapest, Hungary; ‡Medical College, University of Rzeszow, Rzeszow, Poland; §Department of Clinical Development, Cerexa, Inc., Oakland, California; and; ¶Section of Pediatric Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Feigin Center, Houston, Texas.

出版信息

Pediatr Infect Dis J. 2016 Jul;35(7):752-9. doi: 10.1097/INF.0000000000001159.

DOI:10.1097/INF.0000000000001159

PMID:27093162

Abstract

BACKGROUND

Community-acquired bacterial pneumonia (CABP) remains a major infection among children, despite the use of pneumococcal vaccination. Ceftaroline fosamil is a broad-spectrum cephalosporin antibiotic with activity against many bacteria, including Streptococcus pneumoniae (both penicillin-nonsusceptible and multidrug-resistant strains) and Staphylococcus aureus (including methicillin-resistant S. aureus). This article describes the safety, tolerability, and effectiveness of ceftaroline fosamil in the treatment of pediatric patients hospitalized with CABP, from a randomized, active-controlled, observer-blinded clinical study (registration number NCT01530763).

METHODS

Pediatric patients were stratified into 4 age cohorts and randomized (3:1) to receive either intravenous ceftaroline fosamil or ceftriaxone, with optional oral switch for a total treatment duration of 5-14 days. Enrollment was planned for 160 patients. Data collected included demographics, infection characteristics and pathogens. Treatment-emergent adverse events, clinical outcomes, and microbiologic responses were assessed.

RESULTS

Ceftaroline fosamil was well tolerated. Similar percentages of patients in the ceftaroline fosamil (55/121; 45%) and ceftriaxone (18/39; 46%) groups reported treatment-emergent adverse events. Coombs seroconversion was observed in 17% of patients in the ceftaroline fosamil group; however, no evidence of hemolytic anemia or hemolysis was found. No deaths were reported during the study. Ceftaroline fosamil had similar effectiveness to ceftriaxone, with high clinical cure rates at test-of-cure in the modified intent-to-treat population (94/107; 88% and 32/36; 89%, respectively). Three documented S. aureus infections were successfully treated in the ceftaroline group, including one caused by methicillin-resistant S. aureus.

CONCLUSIONS

The results of this study suggest that ceftaroline fosamil may be an important treatment option for pediatric patients hospitalized with CABP.

摘要

背景

尽管使用了肺炎球菌疫苗，但社区获得性细菌性肺炎（CABP）仍是儿童中的主要感染性疾病。头孢洛林酯是一种广谱头孢菌素抗生素，对许多细菌具有活性，包括肺炎链球菌（青霉素不敏感和多重耐药菌株）和金黄色葡萄球菌（包括耐甲氧西林金黄色葡萄球菌）。本文描述了头孢洛林酯在治疗因CABP住院的儿科患者中的安全性、耐受性和有效性，该研究为一项随机、活性对照、观察者盲法的临床研究（注册号NCT01530763）。

方法

儿科患者被分为4个年龄组，并随机（3:1）接受静脉注射头孢洛林酯或头孢曲松治疗，可选择口服转换，总治疗时间为5至14天。计划招募160名患者。收集的数据包括人口统计学、感染特征和病原体。评估治疗中出现的不良事件、临床结局和微生物学反应。

结果

头孢洛林酯耐受性良好。头孢洛林酯组（55/121；45%）和头孢曲松组（18/39；46%）报告治疗中出现不良事件的患者比例相似。头孢洛林酯组17%的患者观察到库姆斯血清学转换；然而，未发现溶血性贫血或溶血的证据。研究期间未报告死亡病例。头孢洛林酯与头孢曲松的有效性相似，在改良意向性治疗人群的治愈试验中临床治愈率较高（分别为94/107；88%和32/36；89%）。头孢洛林酯组成功治疗了3例记录在案的金黄色葡萄球菌感染，其中1例由耐甲氧西林金黄色葡萄球菌引起。