Tuberculosis Research of INA-RESPOND On Drug Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ina-Respond
- 入组人数
- 490
- 试验地点
- 7
- 主要终点
- Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases
研究概览
简要总结
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study.
详细描述
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study. Enrolled subjects will produce the sputum for bacteriological examination of M. tuberculosis by AFB, culture and Xpert. The sputum will also be tested by Xpert for drug resistance test. If the culture is positive, conventional DST will be performed, and M. tuberculosis isolates will be stored for spoligotyping and for future research on TB. All bacteriologicaly confirmed subjects will be followed for outcome assessment.
For all enrolled subjects chest X-ray results, demographic data, TB co-morbidities, symptoms, nutritional status, treatment regimens, compliance and outcome will be collected. In addition, sputum, blood and urine will also be collected for storage.
To estimate the proportion of MDR-TB amongst new and previously treated TB cases.
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To evaluate accuracy of clinical diagnosis by comparing clinically defined TB to laboratory confirmed TB.
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To compare AFB and Xpert MTB/RIF as TB diagnostic tests against culture result.
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To estimate the sensitivity and specificity of Xpert MTB/RIF in detecting Rif susceptibility against DST.
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To estimate the proportion of cured, completed, failed, died and lost to follow up as treatment outcomes on DS-TB and DR-TB cases
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To evaluate the association of treatment success (cured or completed) with the following data:
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Demographics (age, sex)
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TB contact history
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Smoking habit
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Treatment seeking behavior
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Co-morbidities (HIV, DM)
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Primary and secondary drug resistance
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Symptoms
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Cavitary disease
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Nutritional status
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Treatment regimens
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Patient reported compliance
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Numbers of bacteria by AFB test
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TB strains (e.g Beijing)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected of having pulmonary TB
- •Cough ≥ 2 weeks
- •At least one other TB clinical symptom
- •Unexplained weight loss
- •Loss of appetite
- •Hemoptysis
- •Shortness of breath
- •Chest pain
- •Night sweats
- •Suggestive TB on chest x-ray based on pulmonologist or internist consultant of pulmonology opinion
- •Age ≥ 18 years' old
- •Willing to be treated or evaluated at study site
- •Willing to have specimens stored for use in future studies
- •Patient denies having TB treatment for more than 7 days in the last 1 month (30 days).
排除标准
- •Pregnancy or any serious condition includes, but not limited to, liver disease, chronic kidney disease, and psychiatric illness that might interfere with study compliance (based on the clinician judgment).
结局指标
主要结局
Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases
时间窗: 2 months after enrollment
AFB smear and GeneXpert were performed at the microbiology laboratory of the study site. Culture and drug susceptibility tests were conducted at appointed National TB Program Reference Laboratories.
次要结局
- Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up(12- 30 months)
- Factors for Treatment Success.(12-30 months)
- TB Case Category(12-30 months)
- The Performance of Xpert MTB/RIF(12-30 months)
- Factors of Treatment Interruption.(12-30 months)
- The Performance of AFB and Xpert MTB/RIF(12-30 months)