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临床试验/NCT07603128
NCT07603128招募中不适用

Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School11 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年5月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
11

研究概览

简要总结

This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.

详细描述

Adult ICU patients were prospectively and consecutively enrolled across 11 research centers. MDRGNB infection risk predictions were generated within 24 hours of ICU admission using routinely available clinical data. Without interfering with clinical decision-making, the study assessed the discrimination, calibration, and clinical net benefit of the previously developed MDRGNB infection risk prediction model in real-world practice, applying the predefined threshold of 0.318.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age ≥18 years;
  • ICU stay ≥48 hours;
  • At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;
  • Core predictive variables of the model extractable from electronic medical records or laboratory information systems.

排除标准

  • For patients with multiple ICU admissions, only the first ICU stay was retained;
  • Missing or indeterminate primary outcome;
  • Missing key predictive variables that could not be handled according to prespecified rules.

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Dayu

Pharmacist in Charge

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (11)

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