Clinical and Biological Impact of Gut Microbiota on the Development of Bacteremia and Outcomes in Adult Patients With Bacteremia During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Microbiota Analysis
研究概览
简要总结
The widespread use of antibiotics in healthcare, veterinary, and agricultural sectors has significantly contributed to the rise of antimicrobial resistance (AMR), affecting both commensal and pathogenic microorganisms. AMR infections are linked to poorer patient outcomes, prolonged hospital stays, and increased mortality. The COVID-19 pandemic exacerbated this issue through the overuse of antibiotics in hospitalized patients, worsening global resistance trends. Six bacterial species-Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.-are considered urgent targets for new drug development. Advanced diagnostic methods, particularly Next Generation Sequencing (NGS), show promise in improving the detection and management of sepsis and resistant infections. However, effective application of NGS requires interdisciplinary collaboration and specialized expertise, highlighting the need for integrated efforts between research institutions and clinical centers to improve AMR surveillance, diagnostics, and treatment strategies.
详细描述
Excessive consumption of antibiotics in clinical, veterinary, and agricultural settings has led to a huge influx of antibiotics into the environment. This has driven the evolution of antimicrobial resistance (AMR) in commensal and pathogenic microorganisms.
Infections related to AMR microorganisms are associated with an increased incidence of negative outcomes for patients, longer hospital stays, and higher morbidity and mortality rates.
A list of six bacterial species has been drawn up for which it is mandatory to discover and develop new drugs: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.
The pandemic has led to an exponential increase in the use of antibiotics in hospitalized COVID-19 patients, resulting in increased antibiotic resistance and a worsening of the global epidemiological picture.
Laboratories are focusing on certain multi-resistant microorganisms (MDR) such as A. baumannii, P. aeruginosa, K. pneumoniae, and E. coli, considered critical priorities by the World Health Organization (WHO), but Staphylococcus aureus and Enterococcus fecium also continue to pose a problem in the management of patients admitted to intensive care. Faced with this critical issue, there is an increasingly urgent need for new and more effective diagnostic and therapeutic tools capable of controlling its spread. Data collection, as well as analysis of the impact that the pandemic has had on AMR, is essential for implementing surveillance, monitoring, and control systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Patients admitted to the following departments: General Anesthesia and Resuscitation, Cardio-Thoracic-Vascular Anesthesia and Resuscitation, Internal Medicine, and MeCAU
- •Signature of informed consent to participate in the study.
排除标准
- •Absence of informed consent signature
结局指标
主要结局
Microbiota Analysis
时间窗: Through study completion, an average of 1 year
Studying the gut microbiota of patients colonized/infected with multidrug-resistant microorganisms to assess the potential role of protective factors against colonization and bacteremia caused by these microorganisms.
次要结局
- Antibiotic susceptibility(Through study completion, an average of 1 year)
- Analysis of genetic variants(Through study completion, an average of 1 year)
- Phylogenetic correlation of genomic resistance profiles(Through study completion, an average of 1 year)
- Identify the optimal model for rapid diagnosis(Through study completion, an average of 1 year)