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Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial

BACKGROUND & OBJECTIVES: Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections. This multicenter, randomized, parallel-controlled clinical trial was conducted to compare the clinical efficacy, bacterial eradication rates and safety of biapenem and meropenem i...

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Autores principales: Wang, Xiaohui, Zhang, Xiaoke, Zong, Zhiyong, Yu, Rujia, Lv, Xiaoju, Xin, Jianbao, Tong, Chaohui, Hao, Qinglin, Qin, Zhiqiang, Xiong, Ying, Liu, Hong, Ding, Guohua, Hu, Chengping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978993/
https://www.ncbi.nlm.nih.gov/pubmed/24521647
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author Wang, Xiaohui
Zhang, Xiaoke
Zong, Zhiyong
Yu, Rujia
Lv, Xiaoju
Xin, Jianbao
Tong, Chaohui
Hao, Qinglin
Qin, Zhiqiang
Xiong, Ying
Liu, Hong
Ding, Guohua
Hu, Chengping
author_facet Wang, Xiaohui
Zhang, Xiaoke
Zong, Zhiyong
Yu, Rujia
Lv, Xiaoju
Xin, Jianbao
Tong, Chaohui
Hao, Qinglin
Qin, Zhiqiang
Xiong, Ying
Liu, Hong
Ding, Guohua
Hu, Chengping
author_sort Wang, Xiaohui
collection PubMed
description BACKGROUND & OBJECTIVES: Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections. This multicenter, randomized, parallel-controlled clinical trial was conducted to compare the clinical efficacy, bacterial eradication rates and safety of biapenem and meropenem in the treatment of bacterial lower respiratory tract infections and urinary tract infections (UTIs) at nine centres in China. METHODS: Patients diagnosed with bacterial lower respiratory tract infections or UTIs were randomly assigned to receive either biapenem (300 mg every 12 h) or meropenem (500 mg every 8 h) by intravenous infusion for 7 to 14 days according to their disease severity. The overall clinical efficacy, bacterial eradication rates and drug-related adverse reactions of biapenem and meropenem were analyzed. RESULTS: A total of 272 enrolled cases were included in the intent-to-treat (ITT) analysis and safety analysis. There were no differences in demographics and baseline medical characteristics between biapenem group and meropenem group. The overall clinical efficacies of biapenem and meropenem were not significantly different, 94.70 per cent (125/132) vs. 93.94 per cent (124/132). The overall bacterial eradication rates of biapenem and meropenem showed no significant difference, 96.39 per cent (80/83) vs. 93.75 per cent (75/80). Drug-related adverse reactions were comparable in biapenem and meropenem groups with the incidence of 11.76 per cent (16/136) and 15.44 per cent (21/136), respectively. The most common symptoms of biapenem-related adverse reactions were rash (2.2%) and gastrointestinal distress (1.5%). INTERPRETATION & CONCLUSIONS: Biapenem was non-inferior to meropenem and was well-tolerated in the treatment of moderate and severe lower respiratory tract infections and UTIs.
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spelling pubmed-39789932014-04-16 Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial Wang, Xiaohui Zhang, Xiaoke Zong, Zhiyong Yu, Rujia Lv, Xiaoju Xin, Jianbao Tong, Chaohui Hao, Qinglin Qin, Zhiqiang Xiong, Ying Liu, Hong Ding, Guohua Hu, Chengping Indian J Med Res Original Article BACKGROUND & OBJECTIVES: Biapenem is a newly developed carbapenem to treat moderate and severe bacterial infections. This multicenter, randomized, parallel-controlled clinical trial was conducted to compare the clinical efficacy, bacterial eradication rates and safety of biapenem and meropenem in the treatment of bacterial lower respiratory tract infections and urinary tract infections (UTIs) at nine centres in China. METHODS: Patients diagnosed with bacterial lower respiratory tract infections or UTIs were randomly assigned to receive either biapenem (300 mg every 12 h) or meropenem (500 mg every 8 h) by intravenous infusion for 7 to 14 days according to their disease severity. The overall clinical efficacy, bacterial eradication rates and drug-related adverse reactions of biapenem and meropenem were analyzed. RESULTS: A total of 272 enrolled cases were included in the intent-to-treat (ITT) analysis and safety analysis. There were no differences in demographics and baseline medical characteristics between biapenem group and meropenem group. The overall clinical efficacies of biapenem and meropenem were not significantly different, 94.70 per cent (125/132) vs. 93.94 per cent (124/132). The overall bacterial eradication rates of biapenem and meropenem showed no significant difference, 96.39 per cent (80/83) vs. 93.75 per cent (75/80). Drug-related adverse reactions were comparable in biapenem and meropenem groups with the incidence of 11.76 per cent (16/136) and 15.44 per cent (21/136), respectively. The most common symptoms of biapenem-related adverse reactions were rash (2.2%) and gastrointestinal distress (1.5%). INTERPRETATION & CONCLUSIONS: Biapenem was non-inferior to meropenem and was well-tolerated in the treatment of moderate and severe lower respiratory tract infections and UTIs. Medknow Publications & Media Pvt Ltd 2013-12 /pmc/articles/PMC3978993/ /pubmed/24521647 Text en Copyright: © Indian Journal of Medical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Wang, Xiaohui
Zhang, Xiaoke
Zong, Zhiyong
Yu, Rujia
Lv, Xiaoju
Xin, Jianbao
Tong, Chaohui
Hao, Qinglin
Qin, Zhiqiang
Xiong, Ying
Liu, Hong
Ding, Guohua
Hu, Chengping
Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title_full Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title_fullStr Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title_full_unstemmed Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title_short Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
title_sort biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978993/
https://www.ncbi.nlm.nih.gov/pubmed/24521647
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