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临床试验/NCT01511224
NCT01511224Unknown不适用

A Prospective Observational Study of Patients With Drug Resistant Acinetobacter Baumannii Bacteremia Treated With Antibiotics Therapy

National Taiwan University Hospital3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
3
主要终点
Microbiological clearance from blood

研究概览

简要总结

Extensively and multi-drug resistant A. baumannii (AB) represent an emerging threat in hospitals locally and worldwide. There is lack of prospective comparative clinical data to guide optimal strategy for treating such infections. Since it remains unclear how to treat bacteremia caused by AB, the present study aims to enroll patients at multiple sites with extensively drug resistant Acinetobacter species bacteremia receiving different combination therapy to assess treatment outcomes and analyze risk factors associated with mortality.

详细描述

Patients with AB bacteremia receiving antimicrobial therapy are eligible for this multicenter study. Antimicrobial agents are decided at the discretion of the attending clinical team. Clinical data to be collected include patient demographics (age, gender, underlying diseases, Pitt Bacteremia Score [20], duration of ICU stay and hospitalization before the day of first positive blood culture, central venous catheterization), antimicrobial agents on the day of bacteremia, regimens and durations of combination therapy after enrollment, and outcomes (sequential quantification change of blood A. baumannii polymerase chain reaction [PCR], survival at day 30 after enrollment, and adverse drug reactions of antimicrobial agents). Blood sample will be collected on the day of enrollment (Day 0), Day 1, 2, 3 and 7 for PCR quantification of A. baumannii and for genospecies identification. Primary end points are the interval from study enrollment to negative blood A. baumannii PCR and blood sterilization. Secondary end points are survival at 14 and 30-day after enrollment, adverse drug reactions of antimicrobial agents, and risk factors for survival at 30-day after enrollment. Inclusion criteria: 1. Adults >16 years 2. With blood culture isolate(s) A. baumannii. 3. Informed consent gained. Exclusion criteria: 1. Second/repeat episodes of bacteremia 2. Patients who could not or did not receive antimicrobial treatment 3. Patient not admitted to hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ( >16 years)
  • With blood culture isolate(s) A. baumannii
  • Informed consent gained

排除标准

  • Second/repeat episodes of bacteremia
  • Patients who could not or did not receive antimicrobial treatment
  • Patient not admitted to hospital

结局指标

主要结局

Microbiological clearance from blood

时间窗: Day 0,1,2,3,7

Interval from positive to negative blood A. baumannii PCR and blood sterilization.

次要结局

  • Adverse drug reactions(Day 0,1,2,3,7,14)
  • Subsequent infections and colonization(During same admission or within 1 week of discharge)
  • Survival(14, 30, in-hospital stay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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