[A meta-analysis on the efficacy and safety of eravacycline in the treatment of complicated intra-abdominal infections and common infections].

Abstract

Objective: To evaluate the efficacy and safety of eravacycline in the treatment of complicated intra-abdominal infections (cIAI) and common infections. Methods: Literature search was conducted across PubMed, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang Data, and VIP Database to retrieve relevant literature on the treatment of bacterial infections with eravacycline. The search period spanned from the inception of each database to July 9, 2024. Two independent researchers screened the literature, extracted data and assessed the quality of the studies, based on predefined inclusion and exclusion criteria. The R 4.3.3 software was used to conducting the meta-analysis. The relative risk (RR) was used as the effect measure. Heterogeneity was assessed, and publication bias was evaluated. The analysis focused on randomized controlled trials (RCT) to compare the differences in clinical cure rates and risks of adverse events between the eravacycline group and the control group across four populations: the modified intent-to-treat population, the clinically evaluable population, the microbiologically evaluable population, and the microbiologically intent-to-treat population. Additionally, the clinical efficacy rate, microbiological clearance rate, 30 day all-cause mortality rate, and incidence of adverse events associated with eravacycline in non-RCT was analysed. Results: A total of 34 articles were included based on the inclusion and exclusion criteria, encompassing 31 studies involving 2 958 patients. The meta-analysis results from 4 RCT studies showed no statistically significant differences in clinical cure rates for cIAI between the eravacycline group and the control group across various populations (all P>0.05, all I²<50%). The risk of adverse events occurring during treatment was higher in the eravacycline group compared to the control group (RR=1.23, 95%CI: 1.02-1.47, I²=43%), whereas no statistically significant difference was observed in the risk of serious adverse events between the two groups (RR=1.03, 95%CI: 0.65-1.63, I²=0). The meta-analysis results from 27 non-RCT studies indicated that the clinical efficacy rate of eravacycline against multi-site resistant bacterial infections was 71.8%(95%CI: 65.9%-77.7%), I²=86%, and the microbiological clearance rate was 84.1%(95%CI: 72.0%-96.3%), I²=58%. The 30 d all-cause mortality rate was 21.2%(95%CI: 15.7%-27.9%), I²=83%, the overall incidence of adverse events was 7.1%(95%CI: 1.6%-12.5%), I²=70%, and the incidence of treatment-related adverse events was 5.8%(95%CI: 2.2%-10.6%), I²=55%. Conclusion: Based on existing evidence from both RCT and non-RCT studies, eravacycline has demonstrated favorable efficacy and safety in the treatment of cIAI and common infections.