DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH TEST Center: Douala - CAMEROON
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants
研究概览
简要总结
Tuberculosis (TB) is one of the top 10 causes of death in the world. More than 95% of TB deaths are in middle- and middle-income countries. Low incomes and long-term diagnosis promote this persistence. In 2017, Cameroon was the 3rd in the top of 20 countries with the highest estimated numbers of incident TB cases among people living with HIV, based on the severity of their TB burden.
World Health Organization (WHO) encourages the introduction of rapid, non-invasive and cheaper screening tests. In this scope, this study proposes the collection of exhaled breath samples and their analysis through the electronic nose made in Tor Vergata University (TV eNose) to diagnose TB and TB-HIV on their participants.
详细描述
It is a 12 -month dynamic, open, descriptive and analytical type case-control study in adults. The present study intends to recruit , all the Pulmonary TB suspects and case notified by TB Loop-mediated isothermal Amplification(LAMP), sputum culture or GeneXpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) Assay, Pulmonary TB+HIV patients, healthy control patients, HIV patients without TB. Each patient will undergo at least two tests: the Breath Test Measurement and the TB LAMP. The TB LAMP will be used like the reference test for positive TB cases.
The enrolment phase of the participants will take 12 months. After this period, additional 6 months will be dedicated to the data analysis and dissemination of results.
Each patient meeting the inclusion criteria will be asked to join the study. Detailed information will be provided him/her. In case of acceptance the participants will undergo further sampling: breath test measurement. All data will be collected ensuring anonymity and privacy. Standard protocols used in the center will not be changed by the research, but each patient will be asked to provide 1 additional sample (exhaled breath in the bag sampler). Each study participant will be properly informed, and a consent form will be signed.
Preparation to participate: It will be required to patients to avoid drinking, eating, smoking, or brushing their teeth 2 hours before the breath test.
Sampling collection: In order to collect breath samples, two bags will be used, one for collecting airways breath (about 0.5 liter volume) and one for alveolar exhaled air (3 liters). It is asked to the patient after putting a clip nose, to inspire with the mouth and to deeply breath inside the bags through an antibacterial filter connected to the sampling apparatus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accept to participate in the study through a signed informed consent approved by the Ethical Committee (CEI of Douala - Cameroon)
- •Suspected of having TB on clinical base (4SS + or other clinical suggestions) with HIV+/- status
- •Healthy control patient
- •Able to produce exhaled air samples
- •Able to produce sputum samples for TB LAMP test
排除标准
- •Unable to breath normally for 2 minutes due to respiratory illness
- •By discretion of the research team.
结局指标
主要结局
Diagnostic Accuracy value of the TV eNose signal value to differentiate patients with Pulmonary TB to control participants
时间窗: 6 months
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose.The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
Accuracy value of the diagnostic between Pulmonary TB, Pulmonary TB+ HIV patients and control patients with the TV eNose
时间窗: 6 months
Sensitivity, Specificity and Predictive Values; calculated with an Receiver Operating Characteristic (ROC) curve based on the pattern recognition model from dataset measured by the TV eNose. The classification of the signal is generated with a complex pattern recognition software, using the frequency shift in Hertz (Hz), generated by each of the 12 sensors.
次要结局
- Average Days needed to observed a negative result with the device after initiation of treatment.(6 months)
研究者
Yolande Christelle Ketchanji Mougang
Principal Investigator
University of Rome Tor Vergata