Epidemiology, antimicrobial resistance, and outcomes of intra-abdominal infections in China (PRIME): Protocol of a multicenter, prospective, observational study

Abstract

Introduction: Intra-abdominal infections (IAIs) are a common cause of inpatient morbidity and poor clinical outcomes. Currently, epidemiological studies on IAIs are scarce and generally limited to single-center reports or regional initiatives in China. There is still a lack of epidemiological data on patients with IAIs. This study aims to provide an up-to-date investigation of the epidemiologic characteristics, microbiology, antibiotic treatments, risk factors, and outcomes of patients with IAIs in China, and to provide guidelines for clinical practice. Subjects and Methods: The PRIME study is a multicenter, prospective, observational study, which is conducted in 44 hospitals in China. The study is estimated to include 2250 eligible adult patients diagnosed with IAIs. Data including demographics, severity of disease expression, and microbiological data are collected by trained physicians at each center through a designed electronic data capture system. In addition, the application of antimicrobial therapy and source control, organ support, and clinical outcomes are also recorded. The primary outcome is 28-day mortality. Logistic regression analysis will be used to assess the potential risk factors for mortality. The study is designed to be carried out from November 2023 to November 2024. Results: The main demographics and clinical characteristics of all patients will be summarized. The spectrum and antimicrobial resistance information of pathogenic bacteria in patients with IAIs will be reported. The study will also compare differences in the prevalence of antimicrobial resistance in different regions of China. Treatments against IAI, including infection source control and the application of antimicrobial agents, will be recorded and analyzed. The calculation of 28-day mortality rate and the assessment of risk factors for mortality will be conducted. Discussion: By conducting this multicenter observational study, we hope to provide first-hand data on the epidemiologic characteristics, antimicrobial resistance, and outcomes and the latest epidemiological insights of patients with IAIs in China. Conclusions: This multicenter observational study will provide the latest epidemiological insights of patients with IAIs in China.