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OpenTrials
Completed

NCT Number: NCT02219945

ENOSE in Pulmonary Tuberculosis in Yogyakarta

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.

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Key information

Conditions

Pulmonary Tuberculosis Suspected Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Other Specified Chronic Obstructive Pulmonary Disease Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas

Yogyakarta, Jalan Kesehatan No.1, Yogyakarta, 55281, Indonesia

About this study

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.

Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >18yrs
  • voluntarily participating

Exclusion criteria

-

Treatment and study plan

5 min exhaled breath sampling with soft nose clamp

Other

study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc

Other names: AEONOSE portable exhaled breath sampling

Primary outcomes

  1. 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

  1. measuring response to TB treatment over time with the electronic nose

    Time frame: 18 months

    cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment

Sponsors and collaborators

Lead sponsor

Tjip van der Werf

Other

Collaborators

  • Gadjah Mada University
  • The eNose Company

Registry information

Official study title

The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients

Acronym: YOGYATBNOSE

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Aug 19, 2014
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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