Peceleganan Spray for the Treatment of Skin Wound Infections
Authors: Wei Yating , Li Yi , Li Xiaojian , Zhao Yaohua , Xu Junci , Wang Haitao , Rong Xinzhou , Xiong Junlin , Chen Xiaodong , Luo Gaoxing , Lv Guozhong , Lin Cai , Han Chunmao , Yu Hongliang , Zhang Yi , Tang Shijie , Fan Youfen , Tu Jiajin , Xia Chengde , Zu Hongxu , Liu Wenjun , Liu Chang , Liu Jinhui , Zhang Baolin , Nong Qingwen , Li Tianyu , Wang Lei , Song Guodong , Su Yongtao , Chen Zhaohong , Lai Wen , Fu Yanjie , Yu Jia’ao , Zhang Pihong , Yang Weixi , Yao Gang , Zhang Hongyan , Fan Kunwu , Dong Hu , Chen Yuxin , Wu Jun ,   PL-5 Investigators, Yu Xuming , Chao Shengwu , Liu Changling , Shen Yaoming , Xue Chunli , Xing Nan , Fan Guicheng , Yu Changlong , Wang Jingru , Hu Gaozhong , Chu Guoping , Xia Weidong , Wang Xingang , Zhou Xiaofeng , Cai Yuhui , He Weijie , Long Liyun , Di Haiping , Zheng Weicai , Ji Gang , Sun Hui , Li Hongwei , Zhang Linan , Wei Jun , Yang Hong , Zhang Jue , Gao Cong , Wang Zien , Huang Zhifeng , Huang Feng , Gao Xinxin , Zhou Jie , Yu Guojun , Chen Gangquan 
Published: June 2024

ImportancePeceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear.ObjectiveTo assess the safety and efficacy of peceleganan spray for the treatment of wound infections.Design, Setting, and ParticipantsThis 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.InterventionsPatients 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 MeasuresThe 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.ResultsAmong 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;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;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;lt; .001). The adverse events related to the application of peceleganan spray and SSD cream were similar.Conclusions and RelevanceThis 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 RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2100047202