A PROSPECTIVE OBSERVATIONAL COMPARATIVE STUDY OF PREVALENCE AND RISK FACTORS FOR CARBAPENEM RESISTANCE AND NON CARBAPENEM RESISTANCE IN GRAM NEGATIVE BACILLI IN CRITICALLY ILL PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of risk factors (Admission source, Comorbidities, previous exposure to antibiotics, indwelling catheters, mechanical ventilation, severity of illness) for carbapenem resistance and noncarbapenem resistant gram negative bacilli.
研究概览
简要总结
Antibiotics resistance has been emerging as a con in medical practice, specially in critically ill patients.
It is important to know factors responsible for development of resistance to antibiotics.
In last few years, resistance to broad spectrum antibiotics including carbapenems has emerged as a more serious concern.
In this study, we want to know whether factors responsible for development of resistance to carbapenem antibiotics are different from factors for resistance to other antibiotics.
Primary objective of this prospective observational comparative study is to compare risk factors for carbapenem resistance and non carbapenem resistance in critically ill patients.
Secondary objectives are to know prevalence of carbapenem resistant bacteria and distribution of different genetic pattern of carbapenem resistance.
Study will involve ICU patients having growth of resistant gram negative bacilli, for a period of one year .
Patients will be divided into two groups -A. carbapenem resistant B. non carbapenem resistant ,but resistant to at least one other antibiotic.
Different risk factors would be noted (as per study proforma )from detailed patient history,examination,investigations,treatment & outcome of patient in both groups.
PCR based ,FDA approved test would be done to know genetic pattern of carbapenem resistance on some patients (as per clinician decision).
Study will not interfere in sending any investigation or in management of patient,(Management & tests would be done only as per treating physician).
All important risk factors would be compared between above mentioned groups A & B like previous exposure to antibiotics, comorbidites, presence of indwelling devices,severity of illness etc
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted in medical ICU at eternal hospital during study period,patients showing growth of gram negative bacilli in any culture.
排除标准
- •1.Organisms grown in culture ,but in insignificant colony count.
- •Gram negative bacilli sensitive to all antibiotics.
结局指标
主要结局
Comparison of risk factors (Admission source, Comorbidities, previous exposure to antibiotics, indwelling catheters, mechanical ventilation, severity of illness) for carbapenem resistance and noncarbapenem resistant gram negative bacilli.
时间窗: baseline
次要结局
- To know the prevalence of carbapenem resistance in gram negative bacilli.
- To compare 30 day mortality between the two groups(30 day)
- To know the distribution of different genetic pattern of carbapenem resistance in gram negative bacilli.(baseline)