The aim of our study is the development of a simple device that is able to differentiate between sputum from TB patients and non TB patients.With the knowledge and concentration of the VOCs from M. tuberculosis and possible the specific host…
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The GC-MS and PTR-MS VOC profiles will be anlysed by statistical methods e.g.
principal component anlysis, linear discriminant function analysis (DFA),
Partial least square (PLS) analysis. and artificial neural networ. The smell
profiles of the electronic nose will be analysed in the same way as the GC-MS
VOC profiles.
The outcome will be a set of VOCs characteristic for tuberculosis. Part of the
VOCs will be derived from the mycobacteria and part from the host. Perhaps the
host VOCs can divided in infection disease related and TB specific VOCs.
Secondary outcome
N.A.
Background summary
Tuberculosis is an important infectious disease. In the Netherlands there are
about 1200 new TBpatienys /year. In developing countries e.g. sub Saharan
countries the disease is a large problem. The existing diagnosis of lung TB is
based on microscopic examination of sputum, thorax examination, Tuberculin skin
test and the sputum culture results for mycobacteria.
Exhaled breath contains many volatile organic compounds (VOCs). VOCs are also
found in sputum, serum and urine. Recently it became possible to measure the
profile of these compounds by gas chromatography and mass spectrometry(GC-MS)
and by an electronic nose. This results in a VOC or smell profile that by using
statistical analysis can be used for the diagnosis of tuberculosis.
Study objective
The aim of our study is the development of a simple device that is able to
differentiate between sputum from TB patients and non TB patients.
With the knowledge and concentration of the VOCs from M. tuberculosis and
possible the specific host response VOCs, Private Public Partnerships can
develop VOCs specific opto-electronic gas sensors and new e-nose sensors that
perform better than the existing e-nose sensors.
The objectives of this study are
* To characterize and identify the M. tuberculosis or mycobacterial specific
VOCs in cultures of M. tuberculosis and other opportunistic mycobacteria.
* To characterize and identify the M. tuberculosis or mycobacterial specific
VOCs in breath, sputum, serum and urine of TB patients.
* To characterize and identify the host response disease markers in exhaled
breath, sputum, serum and urine.
* To identify the synthesis pathway of the different mycobacterial VOCs
* To identify the cell types and organs involved in the synthesis of the
host-response-VOCs.
* To stimulate Private Public Partnerships in the development of VOCs specific
opto-electronic gas sensors and new e-nose sensors, that perform better than
the existing e-nose sensors.
Study design
The study will have two phases:
* Characterization and identification of the VOCs from M. tuberculosis , M.
avium and M. kansasii when grown in vitro in Middlebrook 7H9 enriched with
OADC, Sauton medium and if possible when grown in human macrophage cell line (
U 937).
* Characterization and identification of VOCs from M. tuberculosis in exhaled
breath, sputum, serum and urine from TB patients, and in addition to
characterize and identify the host response disease markers in exhaled breath,
sputum, serum and urine.
Study burden and risks
N.A.
Meibergdreef 39
1105AZ Amsterdam
NL
Meibergdreef 39
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients suspected of having TB. Some of these will be ZN positive and later confirmed by a positive M. tuberculosis culture; these will be the confirmed TB patients. The Non-TB patients will have a negative Ziehl-Neelsen (ZN) and a negative sputum culture for M. tuberculosis. For Children we will use ZN positive patients or culture positive patients or clinical and epidemiological evidence (family member with active TB) of TB and response to anti TB treatment. The non TB children are initially suspected for having TB but were later found to have another disease.;Cough for more than two weeks
Weight loss
abnormal chest x ray
chest infection suspected
For those under 18 years old, able to voluntarily give a urine specimen
Exclusion criteria
Patients unable to understand nature of study and so unable to give proper informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18684.018.07 |