CTRI/2026/02/103259尚未招募不适用
Combination of Ceftazidime-avibactam and Aztreonam for treatment of bloodstream infections caused by Metallo-B-lactamase producing enterobacteriaceae- a prospective observational study
未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This observational cohort study aims to assess the 30-day all-cause mortality in patients with bloodstream infections (BSIs) caused by MBL-producing Enterobacteriaceae, comparing outcomes between those treated with CAZ-AVI + ATM and those receiving other active antimicrobial regimens. The study will also evaluate independent risk factors associated with mortality in MBL-producing Enterobacteriaceae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients must be more than or equal to 18 years of age, both males and females.
- •Patients have a confirmed diagnosis (blood culture positive) of bloodstream infection (BSI) requiring administration of intravenous (IV) antibacterial therapy.
- •Patients must have an MBL-positive Enterobacterales (for which the imipenem or meropenem minimum inhibitory concentrations is reported as more than or equal to 4 mg/L) isolated from blood within 48 hours prior to enrolment.
- •Patient admitted in ICU.
- •In the case of mixed infection, the patient was allowed to participate in the study if the species were deemed susceptible to Ceftazidime-avibactam + Aztreonam combination (CAZ-AVI + ATM) or the investigator considered that the additional species were colonizers which did not warrant specific treatment.
- •Patients with BSI, with signs and symptoms of systemic infection characterized by at least one of the following: Chills, rigors or fever (temperature of more than or equal to 38.0°C or more than or equal to 100.4°F).
- •Elevated WBC count (more than or equal to 10 000/mm3) or left shift ( more than or equal to 15% immature polymorphonuclear leukocytes).
排除标准
- •Patients with positive culture for any infection prior to ICU admission Pregnant and nursing mothers Patient readmitted to the ICU Patient admitted with burns Patient with known HIV seropositivity Patient had a history of serious allergy such as anaphylaxis, angioedema and bronchospasm, or any serious reactions to any systemic antibacterial, which is allowed per protocol.
- •Refusal to give informed consent.
研究者
Dr Aditi Kaushal
Sir gangaram hospital, new delhi
研究点 (1)
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