一项多中心、随机、观察者盲法、活性对照研究，旨在评估头孢洛林与对照药物相比在患有急性细菌性皮肤和皮肤结构感染的儿科患者中的安全性和有效性。

A Multicenter, Randomized, Observer-blinded, Active-controlled Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infection.

作者信息

Korczowski Bartosz, Antadze Tinatin, Giorgobiani Manana, Stryjewski Martin E, Jandourek Alena, Smith Alexander, O'Neal Tanya, Bradley John S

机构信息

From the *Pediatric Department, Medical College, University of Rzeszów, Rzeszów, Poland; †Department of Abdominal and Traumatology-Orthopedic Surgery, JSC M. Iashvili Children's Central Hospital, Tbilisi, Georgia; ‡Department of Pediatric Surgery, LTD, Children's New Clinic, Tbilisi, Georgia; §Division of Infectious Diseases, Department of Medicine, Centro de Educación Médica e Investigaciones Clinicas (CEMIC), Buenos Aires, Argentina; ¶Department of Clinical Development, Cerexa, Inc., Oakland, CA; and ‖Division of Infectious Diseases, Department of Pediatrics, University of California at San Diego, Rady Children's Hospital, San Diego, CA.

出版信息

Pediatr Infect Dis J. 2016 Aug;35(8):e239-47. doi: 10.1097/INF.0000000000001191.

DOI:10.1097/INF.0000000000001191

PMID:27164462

Abstract

BACKGROUND

Ceftaroline has in vitro activity against bacterial isolates, including methicillin-resistant Staphylococcus aureus. This is the first study to investigate ceftaroline fosamil in pediatric patients with acute bacterial skin and skin structure infections (ABSSSIs).

METHODS

A multicenter, observer-blinded study (NCT01400867) in pediatric patients (2 months-17 years of age) with ABSSSIs. Patients were randomized 2:1 to receive intravenous (IV) ceftaroline fosamil or IV comparator (vancomycin or cefazolin, plus optional aztreonam) with optional switch to oral antibacterials from Day 4. Safety and clinical outcomes were assessed.

RESULTS

Of 163 enrolled patients, 159 received treatment. Treatment groups were comparable for baseline characteristics. Rates of study drug-related treatment-emergent adverse events were similar for ceftaroline fosamil [22% (23/106)] and comparator [23% (12/53)]. One serious adverse event, considered to be related to IV study drug, occurred in the ceftaroline fosamil group (hypersensitivity). In both the treatment groups, 85% (ceftaroline fosamil, 91/107 and comparator, 44/52) of the modified intent-to-treat population achieved early clinical response (≥20% reduction in infection area from baseline). Clinical cure rates at test-of-cure were high [ceftaroline fosamil, 94% (101/107) and comparator, 87% (45/52)]. For patients evaluated 8 to 15 days after the last dose of any antibiotic (IV or oral), from whom methicillin-resistant Staphylococcus aureus was initially isolated, a favorable microbiologic response (reflecting the efficacy of oral/IV therapy and capturing a relapse or reinfection) was achieved with ceftaroline fosamil [89% (16/18)] and comparator [57% (4/7)].

CONCLUSIONS

Ceftaroline fosamil, with optional oral switch, was as well-tolerated and effective in pediatric patients with ABSSSIs as comparator therapy.

摘要

背景

头孢洛林对包括耐甲氧西林金黄色葡萄球菌在内的细菌分离株具有体外活性。这是第一项研究头孢洛林磷霉素在患有急性细菌性皮肤和皮肤结构感染（ABSSSI）的儿科患者中的应用的研究。

方法

一项针对患有ABSSSI的儿科患者（2个月至17岁）的多中心、观察者盲法研究（NCT01400867）。患者按2:1随机分组，接受静脉注射（IV）头孢洛林磷霉素或IV对照药（万古霉素或头孢唑林，加用或不用氨曲南），并可从第4天起改用口服抗菌药物。评估安全性和临床结局。

结果

163例入组患者中，159例接受了治疗。治疗组的基线特征具有可比性。头孢洛林磷霉素组[22%（23/106）]和对照药组[23%（12/53）]的研究药物相关治疗中出现的不良事件发生率相似。头孢洛林磷霉素组发生了1例被认为与静脉注射研究药物有关的严重不良事件（超敏反应）。在两个治疗组中，85%（头孢洛林磷霉素组，91/107；对照药组，44/52）的改良意向性治疗人群实现了早期临床反应（感染面积较基线减少≥20%）。治疗结束时的临床治愈率很高[头孢洛林磷霉素组，94%（101/107）；对照药组，87%（45/52）]。对于在最后一剂任何抗生素（静脉注射或口服）后8至15天进行评估、最初分离出耐甲氧西林金黄色葡萄球菌的患者，头孢洛林磷霉素组[89%（16/18）]和对照药组[57%（4/7）]均实现了良好的微生物学反应（反映口服/静脉治疗的疗效并捕捉复发或再感染情况）。