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Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China

2020年6月14日 更新者:Wen-hong Zhang、Huashan Hospital
The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

研究概览

详细说明

This research is a retrospective, multicenter, case-control study. The purpose of this study is to collect and assess health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

According to inclusion criteria and exclusion criteria, a total of 400 participants with bacteriologically confirmed TB will be recruited and acquired their health-seeking pathways in different clinical institutions of pulmonary tuberculosis. Totally, 20 TB-designated medical institutions will be conducted in depth, covering the eastern region (7), the central region (8) and the western region (5), each hospital will enroll 20 eligible patients on the basis of convenience.

The cohorts are divided into delayed diagnosis and undelayed diagnosis. The former is defined if The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert. By offline or online interview, we aim to collect basic sociodemographic characteristics, symptoms, health-seeking pathway, including: hospital name, the date of each visit, laboratory tests and radiology evaluation results, diagnosis, treatment, medical and transportation costs. Then list the hospitals of previous consultations and trace their classification through the official website of the Health and Medical Commission. Determine whether these hospital are designated institution based on the CDC's publicity. Consult the laboratory facilities by phone.

The primary objective is to gain the median time of pulmonary tuberculosis diagnosis confirmed and the correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis.

The secondary objective is to gain the bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert; the correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis; the sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay; The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.

研究类型

观察性的

注册 (实际的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Anhui
      • Hefei、Anhui、中国
        • Anhui Province Hospital
    • Guangdong
      • Shenzhen、Guangdong、中国
        • The Third People's Hospital of Shenzhen
    • Guangxi
      • Beihai、Guangxi、中国
        • Beihai Tuberculosis Hospital
    • Guizhou
      • Guiyang、Guizhou、中国
        • Guiyang Public Health Clinical Center
    • Hei Longjiang
      • Daqing、Hei Longjiang、中国
        • The 2th Hospital of Daqing
    • Henan
      • Zhengzhou、Henan、中国
        • Henan Province Infectious Diseases Hospital
    • Hubei
      • Wuhan、Hubei、中国
        • Wuhan Medical Treatment Center
    • Hunan
      • Huaihua、Hunan、中国
        • The First People's Hospital of Huaihua
    • Jiangsu
      • Taicang、Jiangsu、中国
        • The First People's Hospital of Taicang
      • Xuzhou、Jiangsu、中国
        • Xuzhou Infectious Diseases Hospital Huimei Liu
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • Jiangxi Province Chest Hospital
    • Jilin
      • Changchun、Jilin、中国
        • Changchun Infectious Diseases Hospital
    • Shandong
      • Jinan、Shandong、中国
        • Shandong Province Chest hospital
    • Shanghai
      • Shanghai、Shanghai、中国
        • Shanghai Public Health Clinical Center
      • Shanghai、Shanghai、中国
        • 905th Hospital of PLA Navy
    • Shanxi
      • Xian、Shanxi、中国
        • Xian Chest Hospital
    • Sichuan
      • Luzhou、Sichuan、中国
        • Southwest Medical University Affiliated Hospital
    • Yunnan
      • Qiubei、Yunnan、中国
        • Qiubei People's Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Hangzhou Red Cross Hospital
      • Wenzhou、Zhejiang、中国
        • Wenzhou Central Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

In the study, 400 patients with bacteriologically confirmed pulmonary tuberculosis(TB) were chose from 20 hospitals, each hospital select 20 patients according to the eligibility criteria randomly. These 20 TB-designated medical institutions are covering the eastern region (7), the central region (8) and the western region (5) among China.

描述

Inclusion Criteria:

  • Bacteriological positive: including positive AFB smear/ culture / molecular test;
  • Agree to accept this survey;

Exclusion Criteria:

  • HIV antibody positive and AIDS patients;
  • Combined with extrapulmonary TB;
  • Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks;

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
delayed diagnosis
The length from the first clinical visit date to the diagnosis confirmed date is more than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.
undelayed diagnosis
The length from the first clinical visit date to the diagnosis confirmed date is equal or less than 14 days. Diagnosis is confirmed by any positive result of anti fast bacteria smear, culture, histological test, and molecular detection such as GeneXpert.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The median time of pulmonary tuberculosis diagnosis confirmed
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
Time from the date of patients' symptoms onset to the date of pulmonary tuberculosis diagnosis confirmed
immediately after asking the medical history and collecting the result of TB diagnosis
The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
We collect the classification and the quality of the first-visit-institution of diagnosis confirmed patients by asking the past medical histories. According to the evidence of duration from symptoms onset to pulmonary TB diagnosis confirmed, use logistic correlation to find the relation between the classification of the first-visit-institution and the diagnosis delay.
immediately after asking the medical history and collecting the result of TB diagnosis

次要结果测量

结果测量
措施说明
大体时间
Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
According to the patients' health-seeking pathways, calculate the test coverage rates including anti fast bacteria smear, tuberculosis culture, and GeneXpert in different clinical institutions. The test coverage rates is acquired by recording the laboratory test reports in medical systems or paper version from patients.
immediately after asking the medical history and collecting the result of TB diagnosis
The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
We collect the fluoroquinolones use evidence of each patients in different clinical institutions by asking the past medical histories and reviewing paper reports from patients as well as medical system. Then use logistic correlation to find the relation between the fluoroquinolones use history and the diagnosis delay of the pulmonary tuberculosis.
immediately after asking the medical history and collecting the result of TB diagnosis
The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
Calculating the distribution of patients' sociodemographic characteristics and correlation between results above and pulmonary tuberculosis diagnosis delay. Patients' sociodemographic characteristics includes: age, sex, marriage status, nation, occupation, education status, annual family income per capita, underlying disease such as diabetes, habits of smoking and habits of drinking alcohol.
immediately after asking the medical history and collecting the result of TB diagnosis
The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients.
大体时间:immediately after asking the medical history and collecting the result of TB diagnosis
According to the past medical history of each pulmonary tuberculosis diagnosis confirmed patients, we collect their onset symptoms and calculate the rate respectively. Then use logistic correlation to find the relation between the onset symptoms and the diagnosis delay of the pulmonary tuberculosis.
immediately after asking the medical history and collecting the result of TB diagnosis

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Wenhong Zhang, PHD、Huashan Hospita

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月8日

初级完成 (实际的)

2019年11月2日

研究完成 (实际的)

2020年1月10日

研究注册日期

首次提交

2020年6月14日

首先提交符合 QC 标准的

2020年6月14日

首次发布 (实际的)

2020年6月17日

研究记录更新

最后更新发布 (实际的)

2020年6月17日

上次提交的符合 QC 标准的更新

2020年6月14日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

We would like to share the study protocol and statistical analysis plan.

IPD 共享时间框架

The data is available currently without expiry date.

IPD 共享访问标准

Please contact y_li11@fudan.edu.cn

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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