The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 389
- Locations
- 2
- Primary Endpoint
- diagnostic precision of electronic nose signal in pulmonary TB
Study Overview
Brief Summary
Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.
Detailed Description
Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data.
The study population consists of six groups:
Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU).
Group 6 - 50 apparently healthy volunteers.
Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age >18yrs
- •voluntarily participating
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1 - 20 PTB patients aged >18yrs
Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
Group 2 - 20 TB suspects > 18 yrs
Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
group 3 - 20 lung patients, non-TB
Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
Group 4 - 20 healthy controls
Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
Group 5 - 7 newly diagnosedMDR PTB pts
Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
group 6 - cohort of TB suspects
300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp
Intervention: 5 min exhaled breath sampling with soft nose clamp (Other)
Outcomes
Primary Outcomes
diagnostic precision of electronic nose signal in pulmonary TB
Time Frame: 18 months
sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
Secondary Outcomes
- measuring response to TB treatment over time with the electronic nose(18 months)
Investigators
Tjip van der Werf
Professor
University Medical Center Groningen