Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatment
研究概览
简要总结
Hypothesis –
We hypothesize that ceftazidime-avibactum would be superior and an effective carbapenem sparing agent compared to extended high dose carbapenems as empirical therapy in management of nosocomial infections caused by carbapenem resistant organisms in patients with ACLF.
Aim -To compare the efficacy and safety of Ceftazidime avibactam and extended infusions of high dose Meropenem as emperical antibiotic in patients of ACLF with nosocomial infections caused by carbapenem resistant organisms.
Primary objective:
• To compare the efficacy of Ceftazidime avibactam over extended infusions of high dose carabapenem as emperical antibiotic in achieving clinical response at day 3 in patients of ACLF with suspected nosocomial infections.
Secondary objectives:
• To study the spectrum of nosocomial infections, bacterial DNA and resistance genes in the context of nosocomial infections in ACLF
• Proportion of patients requiring escalation/de-escalation of antibiotics at day 3
• Incidence of clinical and microbiologic response at day 5 and day 7
• Time to escalation of antibiotics in both groups
• Transfer to icu, mortality, and progression of organ failures and worsening of AARC scores by grade I, SOFA score by point 2.
• Microbiologic outcome (Eradication/Persistence)
• To identify biomarkers of host response to empirical antibiotic regimen
• Transplant free survival at day 15 and day 28
• Proportion of patients made eligible for transplant day 7.
A prospective, Randomized Control Trial. Single centre, Open label, Block randomization will be done, it will be implemented by IWRS method. This study will be conducted in Department of Hepatology, ILBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •ACLF as per APASL criteria
- •ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics.
排除标准
- •Severe septic shock with MOF requiring escalation of antibiotics
- •Patients having known allergies to meropenem or Ceftazidime Avibactam
- •Culture sensitivity showing isolate non susceptible to study drug being investigated.
- •Already on either regimen, receiving meropenem or Ceftazidime Avibactam for more than 48 hours.
- •On mechanical ventilator support PF for less than
- •Patients on immunosuppression medication
- •HCC or other malignancies
- •Pregnancy or Lactation
- •Post Liver Transplantation
- •Refusal to consent 13.
结局指标
主要结局
Proportion of ACLF patients with nosocomial infection by carbapenem resistant organisms showing clinical response at the end of treatment
时间窗: 3 days
次要结局
- Time to escalation of antibiotics(day 5)
- Progression in terms of organ dysfunction/failure at day 5 and 7.(day 5 & 7)
- Incidence of adverse events in both groups(day 28)
- Duration of hospital and ICU stay(day 28)
- Mortality at day 15 and day 28(day 15 and day 28)
研究者
Dr Amanjot Kaur
Institute of Liver and Biliary Sciences