Breath, sputum, serum and urine analysis for the diagnosis of tuberculosis; characterisation of volatile biomarkers for TB

Conditions: TB
tuberculosis
10028440
10024970

Registration Number: NL-OMON31089

Lead Sponsor: Koninklijk Instituut voor de Tropen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 85

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The GC-MS and PTR-MS VOC profiles will be anlysed by statistical methods e.g.<br /><br>principal component anlysis, linear discriminant function analysis (DFA),<br /><br>Partial least square (PLS) analysis. and artificial neural networ. The smell<br /><br>profiles of the electronic nose will be analysed in the same way as the GC-MS<br /><br>VOC profiles.<br /><br><br /><br>The outcome will be a set of VOCs characteristic for tuberculosis. Part of the<br /><br>VOCs will be derived from the mycobacteria and part from the host. Perhaps the<br /><br>host VOCs can divided in infection disease related and TB specific VOCs.</p><br>

Secondary Outcome Measures