一项前瞻性、多中心、随机临床研究比较了 3 天厄他培南与 3 天氨苄西林/舒巴坦治疗局部获得性社区内腹腔感染的疗效和安全性。（T.E.A. 研究：3 天厄他培南对比 3 天氨苄西林/舒巴坦）

A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin-Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam).

机构信息

Unit of General, Emergency and Transplant Surgery, St, Orsola-Malpighi University Hospital, Bologna, Italy.

出版信息

BMC Gastroenterol. 2011 Apr 18;11:42. doi: 10.1186/1471-230X-11-42.

DOI:10.1186/1471-230X-11-42

PMID:21501482

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3090366/

Abstract

BACKGROUND

The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific. This ambiguity is due mainly to the lack of clinical trials on the topic of optimal duration of therapy. It is well known that the overuse of antibiotics has several important consequences such as increased treatment costs, reduced clinical efficacy, and above all, the increased emergence of antibiotic-resistant pathogens. Ampicillin-Sulbactam is a commonly used "first line" antibiotic for intra-abdominal infections. Ertapenem and Ampicillin-sulbactam are recommended as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines.

METHODS/DESIGN: This study is a prospective multi-center randomized investigation. The study will be performed in the Departments of General, Emergency, and Transplant Surgery of Sant'Orsola-Malpighi University Hospital in Bologna, Italy, in the General Surgery Department of the Ospedali Riuniti of Bergamo, Italy, and in the Trauma and Emergency Surgery Department of Maggiore Hospital in Bologna, Italy, and will be conducted by all surgeons willing to participate in the study. The inclusion period of the study will take approximately two years before the planned number of 142 enrolled patients is reached.

DISCUSSION

Ertapenem and Ampicillin-sulbactam are recommended both as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. As one of the discussed topic is the optimal duration of the antibiotic therapy and this ambiguity is due mainly to the lack of clinical trials on the topic, the present study aims for obtain precise data.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00630513.

摘要

背景

外科感染学会（SIS）和美国传染病学会（IDSA）最近发布的指南中概述的关于腹腔内感染患者抗生素治疗适当持续时间的建议是有限且非特异性的。这种不明确性主要是由于缺乏关于最佳治疗持续时间的临床试验。众所周知，抗生素的过度使用会带来几个重要的后果，如治疗成本增加、临床疗效降低，尤其是抗生素耐药病原体的增加。氨苄西林-舒巴坦是治疗腹腔内感染的常用“一线”抗生素。SIS 和 IDSA 指南均推荐厄他培南和氨苄西林-舒巴坦作为局限性腹膜炎的主要治疗药物。

方法/设计：本研究是一项前瞻性多中心随机研究。该研究将在意大利博洛尼亚圣奥尔索拉-马焦雷大学医院的普通外科、急诊和移植外科系、意大利贝加莫的 Ospedali Riuniti 普通外科系以及意大利博洛尼亚的马焦雷医院创伤和急诊外科系进行，由所有愿意参与研究的外科医生进行。研究的纳入期约为两年，直到计划纳入的 142 名患者达到目标数量。