Assessing the accuracy of point-of-care abdominal and thoracic ultrasound for the diagnosis and therapy monitoring in patients with presumed tuberculosis in India and Germany
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 770
- 试验地点
- 1
- 主要终点
- Estimate of sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS
研究概览
简要总结
This is a prospective, multicentre cohortstudy in which the accuracy and the diagnostic yield of TB-focused POC-US andAI interpretation of US will be assessed using a microbiological referencestandard, an extended microbiological reference standard and a compositereference standard among inpatients and outpatients with presumed TB disease.
In presumed tuberculosis patients aged 16 years or older fulfilling the inclusion and exclusioncriteria, POC-US with portable US-device using the FASH-protocol and a defined LUSprotocol will be done. In proven TB patients, POC-US of findings detected willbe followed up at 1, 2, 4, 6 months of anti-tuberculous treatment
Sensitivity and specificity of theFASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS andCRS will be estimated. Description of TB-associated sonographic findings duringtherapy with ranges of time to resolution (median, inter-quartile ranges), sizereduction and compared to patients with therapy failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •patients aged 16 years or older -presenting with symptoms compatible with pulmonary TB (PTB) and/or extra-pulmonary (EPTB): At least one of the symptoms below suggestive of TB (as defined by WHO): oCurrent cough of 2 weeks or of any duration in PLHIV oNight sweats oFever oWeight loss -in Germany another group to enrol will be: patients referred to the study sites because TB is presumed due to radiological, histopathological evidence and where a further TB workup is planned (recognizing the selection bias in the analysis plan) -Willingness to have a study follow-up visit at 2-3 months after enrolment (e.g. not planning to relocate).
- •Sonographic follow-up (primary objective 3): -For patients with sonographic findings of TB disease who are treated with anti-TB drugs and who give consent for follow-up ultrasound, US will be repeated at defined timepoints.
排除标准
- •no consent given -already confirmed diagnosis of TB (by sputum microscopy, culture, PCR) -on anti-tuberculous treatment for more than 24 hours -on anti-tuberculous treatment within the past 60 days -on preventive therapy for TB infection within the past 6 months -Patients presenting with presumed peripheral lymph node TB.
结局指标
主要结局
Estimate of sensitivity and specificity of the FASH-protocol with 95% confidence intervals (CI) for TB against MRS, eMRS and CRS
时间窗: At baseline before the treatment, after 1, 2, 4, 6 months of treatment | treatment) .
Estimate of sensitivity and specificity of various lung ultrasound findings with 95% CI for TB against MRS, eMRS and CRS
时间窗: At baseline before the treatment, after 1, 2, 4, 6 months of treatment | treatment) .
Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failure
时间窗: At baseline before the treatment, after 1, 2, 4, 6 months of treatment | treatment) .
次要结局
- Description of TB-associated sonographic findings during therapy with ranges of time to resolution (median, inter-quartile ranges), size reduction and compared to patients with therapy failure(POC USG done at 1, 2, 4, 6 months of anti-tuberculous treatment)
- Sensitivity and specificity of AI-interpretation of POC-US with 95% CI against an expert interpretation and separately against MRS, eMRS and CRS as reference standard(POCUS USG done at admission/ within 24 hours of TB diagnosis.)