A randomised controlled trial of sulbactam based 3-drug vs 2-drug regimen for treatment of Carbapenem-Resistant Acinetobacter baumannii ventilator associated pneumonia.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate at Day 8: Defined as complete resolution of VAP symptoms and signs (e.g., normalized temperature, white blood cell count, oxygenation, and no purulent secretions) by Day 8 of treatment.
研究概览
简要总结
This is prospective, single blinded, parallel group, superiority randomized controlled trial at the ICUs of AIIMS, New Delhi. The study aims to evaluate whether a three drug sulbactam based regimen comprising of sulbactam, polymyxin b and minocycline is superior to a two drug sulbactam based regimen of sulbactam and minocycline for the treatment of ventilator associated pneumonia caused by carbapenem resistant Acinetobacter baumannii also known as CRAB VAP.
A total of 126 adult patients with microbiologically confirmed CRAB VAP susceptible to polymyxin b and minocycline will be enrolled. Patients will be randomized using variable permuted block randomization into two groups to receive either three drug or two drug regimen for 7 days. The primary outcome is clinical cure at 8 days defined as complete resolution of signs and symptoms of pneumonia. Secondary outcomes will be microbiological eradication, clinical improvement or failure, ICU length of stay, 28 day mortality , incidence of acute kidney injury and adverse drug events.
The rationale stems from limited availability of newer antibiotics and the growing resistance to existing drugs in India. Preliminary observational and in vitro studies have shown reduced mortality with three drug regimen and synergy between sulbactam, polymyxin b and minocycline using pharmacodynamic models. This study seeks to provide high quality evidence to guide treatment protocols for CRAB VAP infections which has high incidence in ICUs, is associated with high mortality rates and has limited therapeutic options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed as Ventilator associated pneumonia as per CDC definition with tracheal aspirate/ BAL cultures positive for Carabapenem Resistant Acinetobacter Baumannii(CRAB) but susceptible to Polymyxin and Minocycline.
排除标准
- •Refusal to participate or lack of written informed consent
- •Known allergies to study drugs
- •Pregnant patients and lactating mothers
- •Poly-microbial VAP
- •Patients not expected to survive beyond study period
- •Pulmonary disease that precludes evaluation of therapeutic response eg lung cancer/lung metastases/active tuberculosis
- •Patients already on RRT at the start of treatment.
结局指标
主要结局
Clinical Cure Rate at Day 8: Defined as complete resolution of VAP symptoms and signs (e.g., normalized temperature, white blood cell count, oxygenation, and no purulent secretions) by Day 8 of treatment.
时间窗: Day 8 of treatment
次要结局
- Microbiological Eradication at Day 8: No growth of CRAB in respiratory samples (ETA or BAL) on Day 8 of treatment.(Day 8 of treatment)
- Clinical Improvement at Day 8 of treatment : Partial resolution of VAP symptoms and signs (e.g., improved oxygenation, reduced fever, or purulent secretions)(Day 8 of treatment)
- Clinical Failure rates : Persistence or worsening of VAP symptoms and signs(Day 8 of treatment)
- ICU Length of Stay (LOS): Duration from randomization to ICU discharge(Time from randomization to ICU discharge)
- 28-Day Mortality: All-cause mortality within 28 days from randomization.(Day 28 after randomization)
- Incidence of Acute Kidney Injury (AKI)(Day 8 of treatment)
研究者
Shailendra Pratap Singh
AIIMS, New Delhi