一项多中心、开放标签、随机、对照、平行组、活性药物对照的III期临床试验，旨在评估硫酸阿贝卡星注射液与万古霉素注射液在确诊为耐甲氧西林金黄色葡萄球菌（MRSA）感染患者中的安全性和有效性。

A Multicentre, Open label, Randomized, Comparative, Parallel Group, Active-controlled, Phase III Clinical Trial to Evaluate Safety and Efficacy of Arbekacin Sulphate Injection versus Vancomycin Injection in Patients Diagnosed with MRSA Infection.

作者信息

Dube Abhay, Deb Ashish Kumar, Das Chandan, Padhye Devdatta, Bhalla Hira, Basu Indraneel, Bs Madhu, Srivastava Pankaj, Agarwal Rajeev, Agrawal Rajendra Prasad, Singh Ram Murti, Kurlekar Uttkrant, Pawar Roshan, Shahavi Vinayaka, Srivastava Ambrish

机构信息

Subharti Medical College and Hospital, Meerut, Uttar Pradesh.

Sudbhawana Hospital, Varanasi, Uttar Pradesh.

出版信息

J Assoc Physicians India. 2018 Dec;66(12):47-50.

PMID:31313549

Abstract

BACKGROUND

Increasing resistance to currently available antimicrobials has led to the development of new agents. Arbekacin is aminoglycoside antibiotic currently used in Japan and Korea for the treatment of infections caused by multi-resistant bacteria including MRSA. Currently there is no published data available for use of Arbekacin in Indian patient population, thus the present study was conducted to evaluate the safety and efficacy of Arbekacin in Indian population.

MATERIAL AND METHODS

The study was a phase III, multi-centre, open-label, randomised comparative, active control study. Subjects with microbiologically confirmed MRSA infection were randomized in the study to receive either Arbekacin sulphate 200 mg OD or Vancomycin hydrochloride 1000 mg BD for a period of 7 to 14 days. The primary endpoint was to evaluate the overall cure rate i.e. Clinical and microbiological cure during the study.

RESULTS

A total of 162 patients were randomized in 2 treatment groups (i.e. 81 patients in each group). Out of these microbiologically confirmed MRSA patients, 153 patients were admitted for SSTI while 9 patients were admitted for CAP. Overall cure rate of MRSA infection (clinical as well as microbiological cure) was comparable in both the treatment groups i.e. 97.5% (79/81) in Arbekacin group and 100 % (79/79) in Vancomycin group (p value: 0.159). Both Arbekacin and Vancomycin were well tolerated by the patients during the study period.

CONCLUSION

Arbekacin can be considered as safe and effective alternative to vancomycin in the management of MRSA infections.

摘要

背景

对现有抗菌药物的耐药性不断增加，促使了新型药物的研发。阿贝卡星是一种氨基糖苷类抗生素，目前在日本和韩国用于治疗包括耐甲氧西林金黄色葡萄球菌（MRSA）在内的多重耐药菌引起的感染。目前，关于阿贝卡星在印度患者群体中的应用尚无公开数据，因此开展本研究以评估阿贝卡星在印度人群中的安全性和有效性。

材料与方法

本研究为一项III期、多中心、开放标签、随机对照、活性对照研究。微生物学确诊为MRSA感染的受试者被随机分为两组，分别接受硫酸阿贝卡星200mg每日一次或盐酸万古霉素1000mg每日两次，疗程为7至14天。主要终点是评估总体治愈率，即研究期间的临床和微生物学治愈率。

结果

共有162例患者被随机分为2个治疗组（即每组81例患者）。在这些微生物学确诊为MRSA感染的患者中，153例因皮肤和软组织感染（SSTI）入院，9例因社区获得性肺炎（CAP）入院。两个治疗组中MRSA感染的总体治愈率（临床和微生物学治愈）相当，阿贝卡星组为97.5%（79/81），万古霉素组为100%（79/79）（p值：0.159）。在研究期间，患者对阿贝卡星和万古霉素的耐受性均良好。