Division of Infection Control Sciences, Department of Clinical Pharmacy, School of Pharmacy, Showa University, Tokyo, Japan
Showa University Research Administration Center, Showa University, Tokyo, Japan.
BMJ Open. 2023 Apr 21;13(4):e069166. doi: 10.1136/bmjopen-2022-069166.
Complicated urinary tract infections (cUTIs) are associated with poor prognosis. The widespread infection of multidrug-resistant Gram-negative uropathogens such as extended-spectrum beta-lactamase-producing bacteria has limited the efficacy of antibiotics used for treating cUTI. Considering the existence of antimicrobial-resistant (AMR) uropathogens, carbapenem is the last-resort antibiotic for cUTI. Given that carbapenem overuse has facilitated the spread of carbapenem-resistant Gram-negative bacteria, carbapenem dependence should be urgently reduced. However, improvement on the clinical outcomes of alternative antibiotics against cUTI caused by AMR uropathogens has not yet been systematically evaluated. Thus, this systematic review and meta-analysis aims to explore and compare the clinical outcomes of cUTI caused by AMR uropathogens between carbapenem and non-carbapenem antibiotics.
The study inclusion criteria will be considered based on the PICO model consisting the following elements: population-adult patients with cUTIs caused by Gram-negative uropathogens; intervention-non-carbapenem class of antimicrobial agents with in vitro activities against Gram-negative uropathogens; comparison-treatment of carbapenem class antibiotics; outcome-a clinical and microbiological cure. Relevant articles published until December 2022 will be systematically searched in February 2023, using electronic databases such as PubMed, the Cochrane Library, EMBASE and ClinicalTrials.gov. Two independent reviewers will screen the select literature and then assess the full-text article to meet the inclusion criteria. The risk of bias will be assessed using the Cochrane risk-of-bias assessment tool. The treatment effects of antibiotics will be estimated as a risk ratio with a 95% CI, using the random-effects model.
This protocol and systematic review will not include direct patient data; thus, informed consent will be waived. The results of this study will be published in an international peer-reviewed journal for wider information dissemination.
CRD42022356064.
复杂尿路感染(cUTI)与不良预后相关。广泛感染多药耐药革兰氏阴性尿路病原体,如产超广谱β-内酰胺酶的细菌,限制了用于治疗 cUTI 的抗生素的疗效。鉴于存在抗菌药物耐药(AMR)尿路病原体,碳青霉烯类是 cUTI 的最后一线抗生素。由于碳青霉烯类药物的过度使用促进了碳青霉烯类耐药革兰氏阴性菌的传播,因此迫切需要减少碳青霉烯类药物的依赖。然而,针对 AMR 尿路病原体引起的 cUTI,替代抗生素的临床疗效改善尚未得到系统评估。因此,本系统评价和荟萃分析旨在探索和比较 AMR 尿路病原体引起的 cUTI 中碳青霉烯类和非碳青霉烯类抗生素的临床疗效。
本研究的纳入标准将基于包含以下要素的 PICO 模型进行考虑:人群-患有由革兰氏阴性尿路病原体引起的 cUTI 的成年患者;干预-对革兰氏阴性尿路病原体具有体外活性的非碳青霉烯类抗菌药物;比较-碳青霉烯类抗生素的治疗;结局-临床和微生物学治愈。将于 2023 年 2 月系统检索截至 2022 年 12 月发表的相关文章,使用电子数据库,如 PubMed、Cochrane 图书馆、EMBASE 和 ClinicalTrials.gov。两名独立审查员将筛选入选文献,然后评估全文文章以满足纳入标准。使用 Cochrane 偏倚风险评估工具评估偏倚风险。使用随机效应模型,将抗生素的治疗效果估计为风险比及其 95%置信区间。
本方案和系统评价不包括直接的患者数据;因此,将放弃知情同意。本研究的结果将发表在国际同行评议期刊上,以更广泛地传播信息。
PROSPERO 注册号:CRD42022356064。