Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections
| Autor: | Guodong Song, Cai Lin, Wen Lai, Jinhui Liu, Chunmao Han, Xiaojian Li, Jun Wu, Bingwei Sun, Yongtao Su, Pihong Zhang, Baolin Zhang, Kunwu Fan, Xuming Yu, Chen Yuxin, Lei Wang, Yating Wei, Jia'ao Yu, Akebaer Ahemaiti, Haitao Wang, Guozhong Lv, Hongxu Zu, Feng Zhu, Geng Ji, Yi Zhang, Wenjun Liu, Chen Mingxia, Chang Liu, Xinzhou Rong, Yaohua Zhao, Li Yi, Cheng-de Xia, Dong Hu, Xiaodong Chen |
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| Rok vydání: | 2021 |
| Předmět: |
History
medicine.medical_specialty Polymers and Plastics business.industry Ethics committee Consolidated Standards of Reporting Trials Industrial and Manufacturing Engineering law.invention Pharmacokinetic analysis Clinical trial Randomized controlled trial law Internal medicine Medicine In patient Clinical efficacy Business and International Management business Adverse effect |
| Zdroj: | SSRN Electronic Journal. |
| ISSN: | 1556-5068 |
| DOI: | 10.2139/ssrn.3951773 |
| Popis: | Background: Antimicrobial Peptide PL-5 (Peceleganan) Spray is a novel topical antimicrobial agent targeted on the treatment of skin wound infections. Methods: We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 Spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day post-treatment (D5), the bacteria clearance rate and the overall efficacy rate at the mentioned two timepoints. The safety outcomes included adverse reactions and pharmacokinetic analysis post-treatment. Findings: Between Jul 29, 2020, and May 10, 2021, a total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 91·6%, 83·6%, 85·0% for the 1 ‰ PL-5, 2 ‰ PL-5, 4 ‰ PL-5 groups respectively, as compared with 60% for the control group. The efficacy rate between each PL-5 group and the control group was significantly different (P |
| Databáze: | OpenAIRE |
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