Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
研究概览
简要总结
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study treatment is not blinded, however the rectal and nasal swabs of the control group will be blinded to the investigator and the participant.
In all participants, microbiology department will immediately process the samples (swabs) in order to identify a potential colonization by MDR bacteria. Results will be available in the SAP system in patients randomized to the surveillance group but will remained blinded for the clinical investigators in the control group. Blinding will be broken when the patient completes the follow-up period (28 days).
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
- •Cirrhotic patients with acute decompensation aged ≥18 years.
- •Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
- •Signed informed consent or consent given by their legal representatives or close relatives.
排除标准
- •Bacterial infection lasting for > 48 hours.
- •Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
- •MDR colonization or infection in the last month.
- •Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
- •Pregnant and/or breast-feeding woman.
- •Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
研究组 & 干预措施
Conventional antibiotic strategies
The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona.
干预措施: Conventional antibiotic strategies (Other)
Regimens guided by epidemiological surveillance
The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
干预措施: Regimens guided by epidemiological surveillance (Other)
结局指标
主要结局
Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
时间窗: 28 days
Measured by the appearance of new colonizations and/or infections by MDROs.
次要结局
- Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.(Through study completion, an average of 28 days)
- Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.(During hospitalization (until discharge), assessed up to day 28 and at 28 days.)
- Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.(During hospitalization (until discharge), assessed up to day 28 and at 28 days.)
- Infection resolution rate with initial and final strategies in both treatment arms.(Through study completion, an average of 28 days)
- Days of admission to the ICU if needed.(Through study completion, an average of 28 days)
- Health costs(Through study completion, an average of 28 days)
- Hospital survival(During hospitalization (until discharge), assessed up to day 28.)
- Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.(During hospitalization (until discharge), assessed up to day 28 and at 28 days.)
- Probability of antibiotic resistance development during hospitalization in both treatment arms.(During hospitalization (until discharge), assessed up to day 28.)
- Rate of antibiotic resistance development during hospitalization in both treatment arms.(During hospitalization (until discharge), assessed up to day 28.)
- Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.(Through study completion, an average of 28 days)
- Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.(Through study completion, an average of 28 days)
- Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.(During hospitalization (until discharge), assessed up to day 28 and at 28 days.)
- Evolution of score Child-Pugh in both treatment arms.(Through study completion, an average of 28 days)
- Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.(Through study completion, an average of 28 days)
- Days of hospital stay(Through study completion, an average of 28 days)
- Number of rehospitalizations.(Through study completion, an average of 28 days)
- Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.(Through study completion, an average of 28 days)
- Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.(Through study completion, an average of 28 days)
- Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.(Through study completion, an average of 28 days)
- 28-day survival(28 days)
- Antibiotics consumption(Through study completion, an average of 28 days)
研究者
Eva Bonfill
Project Manager
Institut d'Investigacions Biomèdiques August Pi i Sunyer