Peceleganan Spray for the Treatment of Skin Wound Infections
Authors: Yating Wei, Yi Li, Xiaojian Li, Yaohua Zhao, Junci Xu, Haitao Wang, Xinzhou Rong, Junlin Xiong, Xiaodong Chen, Gaoxing Luo, Guozhong Lv, Cai Lin, 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, Wen Lai, Yanjie Fu, Jia’ao Yu, Pihong Zhang, Weixi Yang, Gang Yao, Hongyan Zhang, Kunwu Fan, Hu Dong, Yuxin Chen, Jun Wu, Xuming Yu, Shengwu Chao, Changling Liu, Yaoming Shen, Chunli Xue, Nan Xing, Guicheng Fan, Changlong 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, Hongwei Li, Linan Zhang, Jun Wei, Hong Yang, Jue Zhang, Cong Gao, Zien Wang, Zhifeng Huang, Feng Huang, Xinxin Gao, Jie Zhou, Guojun Yu, Gangquan Chen
Journal: JAMA Network Open (2024)

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 treatment group and 183 (96.8%) in the 1% SSD control group completed the trial (n = 558). Of these, 361 (64.7%) were men, and the mean (SD) age was 48.6 (15.3) years. The demographic characteristics were similar between groups. On day 8, clinical efficacy was achieved by 339 patients (90.4%) in the treatment group and 144 (78.7%) in the control group ( P &amp;amp;lt; .001). On day 5, clinical efficacy was achieved by 222 patients (59.2%) in the treatment group and 90 (49.2%) in the control group ( P = .03). On day 8, bacterial clearance was achieved by 80 of 334 patients (24.0%) in the treatment group and in 75 of 163 (46.0%) in the control group ( P &amp;amp;lt; .001). On day 5, bacterial clearance was achieved by 55 of 334 patients (16.5%) in the treatment group and 50 of 163 (30.7%) in the control group ( P &amp;amp;lt; .001). The adverse events related to the application of peceleganan spray and SSD cream were similar. Conclusions and Relevance This randomized clinical trial found that peceleganan spray is a safe topical antimicrobial agent with a satisfactory clinical efficacy rate for the treatment of skin wound infections, while the effectiveness of bacterial clearance remains uncertain. Trial Registration Chinese Clinical Trial Registry Identifier: ChiCTR2100047202