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临床试验/CTRI/2019/02/017672
CTRI/2019/02/017672尚未招募不适用

Multicentric study to evaluate the efficacy of TimBresoftware as compared to standard screening modalities in subjects clinically suspected of pulmonary tuberculosis

Docturnal Pvt Ltd1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2019年2月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
1
主要终点
2. Evaluate the diagnostic performance of TimBre with standard screening modalities as measured by sensitivity, specificity, PPV and NPV

研究概览

简要总结

Tuberculosis (TB)is one of the oldestknown disease to affect humans caused by Mycobacterium tuberculosis usuallyaffecting the lungs although other organs can also be involved. (1) Pulmonarytuberculosisis a global heath burden affecting predominantly low and middleincome countries. TB is one of the top 10 leading causes of death and theleading cause from a single infectious agent. (2) According to WHO database2017, 1 million children became ill with TB and another 230000 children died ofTB. Death due to TB was estimated to be around 1.3 million among HIV negativeindividuals with an additional 3 lakhs death from HIV positive individuals (3)The disease mainly spreads through airway spread of droplet nuclei from cough.

A series of experiment conducted in1960s showed that the spread of droplet nuclei was more during cough than bytalking or singing. (5) Since then there was a number of studies focusing onthe cough characteristics such as cough frequency, diurnal variation etc. Proanoet al (6) studied the dynamics of cough frequency in 64 adults undergoingtreatment for pulmonary TB using a semi-automated ambulatory monitor Cayetano Cough Monitor. The study showed that coughs were more frequent in daytime. Two weeksof antitubercular therapy (ATT) reduced cough frequency and achieved cultureconversion in one third of patients.The Cavetano Cough Monitor was validated inpatients with TB and showed a sensitivity of 75.5%

Early diagnosis of pulmonary TB in an individual is crucial for TBcontrol because it helps in early initiation of treatment as well as reducefurther spread in the community. Chest X ray though useful in diagnosis haslimitations due to lack of specificity and presence of atypical findings thatcan mimic other conditions. Definitive diagnosis depends on recovery of theorganism in culture or identification using DNA or RNA amplification techniques

TimBre is a Non-Invasive & Point of Care Solution from Docturnalthat screens for Pulmonary Tuberculosis Screening using a Microphone Array thatis connected to a Mobile Phone RunningTimBre App.The device is a XY Microphone Array that comes with a filter(pop/wind) which needs to be replaced after a positively screened result isobtained to avoid the bacilli spread to the next suspect/patient. It supportsboth USB & battery & an additional connector connects to Mobile PhoneJack to the Line in jack of the Microphone Array. This can also be replaced bya USB 2.0 cable. Optionally a tripod is available as needed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants of either gender above 18 years with symptoms suggestive of Pulmonary TB such as, Cough >2 weeks,Fever >2 weeks,Significant weight loss (more than 4.5 kg or 5% in 6 to 12 months), Haemoptysis, Any abnormalities in chest radiography.
  • Who are willing to give written informed consent and comply with study related visit and procedure.

排除标准

  • Patients with extra pulmonary TB
  • Any psychological and/or pathological condition that would interfere with study participation in the opinion of the investigator.

结局指标

主要结局

2. Evaluate the diagnostic performance of TimBre with standard screening modalities as measured by sensitivity, specificity, PPV and NPV

时间窗: 3 months

1. To assess non-inferiority of sensitivity of TimBre software to not more than 10% of the sensitivity of standard screening modalities

时间窗: 3 months

次要结局

  • . To study the influence of patient characteristics on diagnostic accuracy of TimBre software.(2. To study the efficacy of TimBre software in differentiating drug sensitive cases from drug resistant TB cases)

研究者

发起方
Docturnal Pvt Ltd
申办方类型
Other [company]

研究点 (1)

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