NCT04383106已完成不适用
Bowel Colonization With Multi-drug Resistant Bacterial Species in Hospitalized Patients With acute-on Chronic Liver Failure (ACLF), and Its Relationship With Extra-intestinal Infectious Events and Short-term Outcomes.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients
研究概览
简要总结
Bowel colonization with anti-microbial resistant bacteria increases the risk of clinical infections. Infections caused by anti-microbial resistant bacteria have been associated with increased mortality, prolonged hospital stay, and increased costs. In addition, with the emergence of carbapenemase resistant bacterial species, there may not be any effective therapy for patients infected with such resistant species.
Bowel colonization with anti-microbial resistant bacteria is an established risk factor for infections due to resistant bacteria, especially in transplanted patients and in intensive care unit. In this study we will study whether bowel colonisation in Acute on Chronic Liver Failure patient increases the risk of infection development in extra intestinal sites.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Acute on Chronic Liver Failure admitted to the ward/High Dependency Unit/Intensive Care Unit.
排除标准
- •Patients on immunosuppressant medications or on daily steroids (excluding inhaled steroids) or >2 weeks.
- •Patients with additional primary or acquired immunosuppressive states like hypogammaglobinemia, post-splenectomy, human immunodeficiency virus (HIV) infection etc.
- •Neutropenia defined as absolute neutrophil count or total white blood cell count (WBC) <500/mm3
- •Patients with extra-hepatic malignancy or on cytotoxic chemotherapy.
- •Patients with ileus, bowel hypomotility, severe constipation requiring laxatives/purgatives or enemas to evacuate.
- •Patients with fresh or altered blood in stools.
- •Patients with anatomical predisposition to infection/ bacterial seeing like prosthesis or foreign body. Patients with exfoliative skin conditions, significant mucosal ulcerations, or skin ulcers. Patients who have received > 2 weeks of antibiotics before current admission.
- •Pregnant patients.
结局指标
主要结局
Fecal isolation rates of carbapenem resistant gram negative bacterial species (CR-GNB) among hospitalized ACLF patients
时间窗: Day 28
次要结局
- Fecal isolation rates of Vancomycin-resistant enterococci (VRE) species among hospitalized ACLF patients(Day 28)
- Fecal carriage rates of C. difficile among hospitalized ACLF patients.(Day 28)
- Correlation of the fecal carriage rates of resistant bacterial species with etiology and severity of ACLF, including onset and resolution of organ failure (OF).(Day 28)
- Fecal isolation rates of Extended Spectrum Beta-Lactamases (ESBL) producing gram negative bacterial species among hospitalized ACLF patients.(Day 28)
- Correlation of fecal carriage of resistant bacterial species with antibiotic exposure antibiotic type and duration(Day 28)
- Concordance of bowel colonizing resistant bacterial species, with concurrent or subsequent infecting bacterial isolates from extra-intestinal sites(Day 28)
- Timeline of bowel colonization with resistant bacterial species among hospitalized ACLF patients(Day 28)
- Factors predisposing patients colonized with resistant bacterial species to develop extra-intestinal infectious events due to the same species(Day 28)
- Correlation of fecal carriage resistant bacterial species with patient outcomes (admission duration or survival duration, short-term survival to discharge, readmission rates, and 30-day survival(Day 28)
研究者
研究点 (1)
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