Tuberculosis; Pulmonary, Confirmed, Unspecified Means Clinical Trial
Official title:
Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China
| Verified date | June 2020 |
| Source | Huashan Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | January 10, 2020 |
| Est. primary completion date | November 2, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
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; |
| Country | Name | City | State |
|---|---|---|---|
| China | Beihai Tuberculosis Hospital | Beihai | Guangxi |
| China | Changchun Infectious Diseases Hospital | Changchun | Jilin |
| China | The 2th Hospital of Daqing | Daqing | Hei Longjiang |
| China | Guiyang Public Health Clinical Center | Guiyang | Guizhou |
| China | Hangzhou Red Cross Hospital | Hangzhou | Zhejiang |
| China | Anhui Province Hospital | Hefei | Anhui |
| China | The First People's Hospital of Huaihua | Huaihua | Hunan |
| China | Shandong Province Chest hospital | Jinan | Shandong |
| China | Southwest Medical University Affiliated Hospital | Luzhou | Sichuan |
| China | Jiangxi Province Chest Hospital | Nanchang | Jiangxi |
| China | Qiubei People's Hospital | Qiubei | Yunnan |
| China | 905th Hospital of PLA Navy | Shanghai | Shanghai |
| China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
| China | The Third People's Hospital of Shenzhen | Shenzhen | Guangdong |
| China | The First People's Hospital of Taicang | Taicang | Jiangsu |
| China | Wenzhou Central Hospital | Wenzhou | Zhejiang |
| China | Wuhan Medical Treatment Center | Wuhan | Hubei |
| China | Xian Chest Hospital | Xian | Shanxi |
| China | Xuzhou Infectious Diseases Hospital Huimei Liu | Xuzhou | Jiangsu |
| China | Henan Province Infectious Diseases Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Huashan Hospital |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The median time of pulmonary tuberculosis diagnosis confirmed | 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 | |
| Primary | The correlation between the classification of the first-visit-institution and the diagnosis delay of the pulmonary tuberculosis | 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 | |
| Secondary | Bacteriology examination coverage rate: anti fast bacteria smear, tuberculosis culture, and GeneXpert. | 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 | |
| Secondary | The correlation between the use of fluoroquinolones as anti-infection treatment before tuberculosis diagnosis confirmed and the diagnosis delay of the pulmonary tuberculosis | 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 | |
| Secondary | The sociodemographic characteristics of patients with or without pulmonary tuberculosis diagnosis delay. | 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 | |
| Secondary | The rates of onset symptoms and its correlation to diagnosis delayed of pulmonary tuberculosis diagnosis confirmed patients. | 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 |