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- Title
Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial.
- 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
- Abstract
Key Points: Question: Is the topical antimicrobial peptide agent peceleganan safer and more effective in the treatment of wound infections than the positive control drug silver sulfadiazine? Findings: This multicenter, open-label, phase 3 randomized clinical trial included 570 patients and showed that on posttreatment day 8, the clinical efficacy of the treatment group was statistically higher than that of the control group. There were no severe adverse events related to the application of peceleganan spray. Meaning: These findings suggest that peceleganan spray is safe and has a higher clinical efficacy rate for the treatment of skin wound infections than the positive control drug silver sulfadiazine. This phase 3 randomized clinical trial evaluates the safety and efficacy of peceleganan, an antimicrobial peptide spray, compared with a conventional topical antibiotic silver sulfadiazine in patients with skin wound infections. 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 <.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 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
- Subjects
CHINA; ANTIBIOTICS; VITAL signs; BLOOD testing; SATISFACTION; RESEARCH funding; STATISTICAL sampling; SKIN care; WOUND infections; ANTIMICROBIAL peptides; TREATMENT effectiveness; HOSPITALS; RANDOMIZED controlled trials; DESCRIPTIVE statistics; CHI-squared test; ELECTROCARDIOGRAPHY; RESEARCH; ELECTRONIC health records; SILVER sulfadiazine; BACTERIAL diseases; COMPARATIVE studies; DATA analysis software; CONFIDENCE intervals
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2415310
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.15310