Peceleganan Spray for the Treatment of Skin Wound Infections

Author:

Wei Yating1,Li Yi2,Li Xiaojian3,Zhao Yaohua4,Xu Junci5,Wang Haitao6,Rong Xinzhou7,Xiong Junlin8,Chen Xiaodong9,Luo Gaoxing10,Lv Guozhong11,Lin Cai12,Han Chunmao13,Yu Hongliang14,Zhang Yi15,Tang Shijie16,Fan Youfen17,Tu Jiajin18,Xia Chengde19,Zu Hongxu20,Liu Wenjun21,Liu Chang22,Liu Jinhui23,Zhang Baolin24,Nong Qingwen25,Li Tianyu26,Wang Lei27,Song Guodong28,Su Yongtao29,Chen Zhaohong30,Lai Wen31,Fu Yanjie32,Yu Jia’ao33,Zhang Pihong34,Yang Weixi35,Yao Gang36,Zhang Hongyan37,Fan Kunwu1,Dong Hu38,Chen Yuxin38,Wu Jun139, ,Yu Xuming40,Chao Shengwu40,Liu Changling40,Shen Yaoming40,Xue Chunli40,Xing Nan40,Fan Guicheng40,Yu Changlong40,Wang Jingru40,Hu Gaozhong40,Chu Guoping40,Xia Weidong40,Wang Xingang40,Zhou Xiaofeng40,Cai Yuhui40,He Weijie40,Long Liyun40,Di Haiping40,Zheng Weicai40,Ji Gang40,Sun Hui40,Li Hongwei40,Zhang Linan40,Wei Jun40,Yang Hong40,Zhang Jue40,Gao Cong40,Wang Zien40,Huang Zhifeng40,Huang Feng40,Gao Xinxin40,Zhou Jie40,Yu Guojun40,Chen Gangquan40

Affiliation:

1. Departments of Burn and Plastic Surgery and Wound Repair, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People’s Hospital, Shenzhen, China

2. Qinghai University Affiliated Hospital, Xining, China

3. Guangzhou Red Cross Hospital, Guangzhou, China

4. Jiangyin People’s Hospital, Jiangyin, Wuxi, China

5. Huizhou Municipal Central Hospital, Huizhou, China

6. Weihai Municipal Hospital, Weihai, China

7. Guangzhou First People’s Hospital, Guangzhou, China

8. Ganzhou Municipal Hospital, Ganzhou, China

9. The First People’s Hospital of Foshan, Foshan, China

10. The Southwest Hospital, Chongqing, China

11. Affiliated Hospital of Jiangnan University, Wuxi, China

12. The First Affiliated Hospital of Wenzhou Medical University, New District of the First Hospital of Wenyi Hospital, Wenzhou, China

13. The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China

14. Yuncheng Central Hospital, Yuncheng, China

15. Affiliated Hospital of Nantong University, Nantong, China

16. The Second Affiliated Hospital of Shantou University Medical College, Shantou, China

17. Ningbo Huamei Hospital of University of the Chinese Academy of Sciences, Ningbo, China

18. Ganzhou People’s Hospital, Ganzhou, China

19. Zhengzhou First People’s Hospital, Zhengzhou, China

20. The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

21. The Second Affiliated Hospital of Kunming Medical University, Kunming, China

22. Affiliated Hospital of Jiangsu University, Zhenjiang, China

23. Jilin Province People’s Hospital, Changchun, China

24. First Hospital of Shanxi Medical University, Taiyuan, China

25. The First Affiliated Hospital of Guangxi Medical University, Nanning, China

26. Nanshi Hospital of Nanyang, Nanyang, China

27. Zhongda Hospital Southeast University, Nanjing, China

28. Jinan Central Hospital, Jinan City, China

29. Peking University Care Luzhong Hospital, Zibo, China

30. Fujian Medical University Union Hospital, Fuzhou, China

31. Guangdong Provincial People’s Hospital, Guangzhou, China

32. Linyi People’s Hospital, Linyi, China

33. The First Hospital of Jilin University, Changchun, China

34. Xiangya Hospital of Central South University, Changsha, China

35. The Affiliated Huaian No. 1 People Hospital of Nanjing Medical University, Huaian, China

36. The First Affiliated Hospital of Nanjing Medical University, Nanjing, China

37. The First Affiliated Hospital of Nanchang University, Nanchang, China

38. Jiangsu Protelight Pharmaceutical & Biotechnology Co, Ltd, Jiangyin, China

39. Human Histology and Embryology Section, Department of Surgery, Dentistry, Paediatrics and Gynecology, University of Verona Medical School, Verona, Italy

40. for the PL-5 Investigators

Abstract

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 < .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 < .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 < .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

Publisher

American Medical Association (AMA)

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