Peceleganan Spray for the Treatment of Skin Wound Infections

作者：Yating Wei, Yi Li, Xiaojian Li, Yaohua Zhao, Junci Xu, Haitao Wang, Xinzhou Rong, Junlin Xiong, Xiaodong Chen, Gaoxing Luo, Guozhong Lv, Lin Cai, Chunmao Han, Hongliang Yu, Yi Zhang, Shijie Tang, Youfen Fan, Jiajin Tu, Chengde Xia, Hongxu Zu, Wenjun Liu, Chang Liu, Jinhui Liu, Baolin Zhang, Qingwen Nong, Tianyu Li, Lei Wang, Guodong Song, Yongtao Su, Zhaohong Chen, Lai Wen, Yanjie Fu, Jiaao Yu, Pihong Zhang, Weixi Yang, Gang Yao, Hongyan Zhang, Kunwu Fan, Dong Hu, Yuxin Chen, Jun Wu, PL-5 Investigators, Xuming Yu, Shengwu Chao, Changling Liu, Yaoming Shen, Chunli Xue, Nan Xing, Guicheng Fan, Chang-long Yu, Jingru Wang, Gaozhong Hu, Guoping Chu, Weidong Xia, Xingang Wang, Xiaofeng Zhou, Yuhui Cai, Weijie He, Liyun Long, Haiping Di, Weicai Zheng, Gang Ji, Hui Sun, LI Hong-we, Linan Zhang, Jun Wei, Hong Yang, Jue Zhang, Cong Gao, Zi-En Wang, Zhifeng Huang, Feng Huang, Xinxin Gao, Jie Zhou, Guojun Yu, Gangquan Chen · 发表于：JAMA Network Open · 年份：2024 · DOI：10.1001/jamanetworkopen.2024.15310 · 被引用次数：15 · 研究领域：Wound Healing and Treatments、Surgical site infection prevention、Pressure Ulcer Prevention and Management

Importance: Peceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear. Objective: To assess the safety and efficacy of peceleganan spray for the treatment of wound infections. Design, Setting, and Participants: This multicenter, open-label, phase 3 randomized clinical trial recruited and followed up 570 adult patients diagnosed with secondary open wound infections from 37 hospitals in China from August 23, 2021, to July 16, 2022. Interventions: Patients were randomized to 2 groups with a 2:1 allocation. One group received treatment with 2% peceleganan spray (n = 381) and the other with 1% silver sulfadiazine (SSD) cream (n = 189). Main Outcomes and Measures: The primary efficacy outcome was the clinical efficacy rate (the number of patients fulfilling the criteria for efficacy of the number of patients receiving the treatment) on the first day following the end of treatment (day 8). The secondary outcomes included the clinical efficacy rate on day 5 and the bacterial clearance rate (cases achieving negative bacteria cultures after treatment of all cases with positive bacteria cultures before treatment) on days 5 and 8. The safety outcomes included patients' vital signs, physical examination results, electrocardiographic findings, blood test results, and adverse reactions. Results: Among the 570 patients randomized to 1 of the 2 groups, 375 (98.4%) in the 2% peceleganan treatmen...