Tuberculosis Clinical Trial
Official title:
A Blinded, Cross-sectional, Diagnostic Evaluation Study Performed in Pulmonary TB Suspects at the TB Dispensary for Sector 4 of the Marius-Nasta-Institute in Bucharest, Romania
The diagnosis of tuberculosis (TB) and especially the detection of drug resistance of
tuberculosis mycobacteria can be time consuming and costly. New and rapid diagnostic tests
are needed to improve early case detection and correct initiation of treatment.
In the planned cross-sectional diagnostic evaluation study the investigators are aiming for
the assessment of several new TB diagnostics (e.g. new AID strip assays and TrDNA assay in
urine) in TB suspects who are presenting themselves to the pulmonary ambulance (TB dispensary
for sector 4) at the Marius Nasta Institute (MNI). The study will be conducted in a
co-operation between the MNI and the German Center for Infection Research (DZIF).
Up to 400 TB suspects will be consecutively screened for their eligibility for participation
in the study. In those who are eligible (according to the criteria listed above) to
participate, 2 sputum samples and one urine will be collected for standard diagnostic testing
for TB in sputum (smear, Line Probe Assays and culture methods, as defined in the national
guidelines) and for the evaluation of the new assays; one blood sample will be collected for
analysis of lipoprotein profiles in serum of TB patients. Further, a HIV test and a clinical
examination will be performed in all study subjects. Information on risk factors for TB
disease (co-morbidities such as diabetes mellitus, co-medication such as steroids and risk
behaviour such as smoking) will be also documented.
All TB tests results and data which are generated in the study will be collected on
standardized study forms and entered in a password-secured data base. TB tests results will
be also shared with the medical staff treating the patients who are participating in the
study.
One follow up visit will be performed after 8 weeks in order to evaluate the clinical
progress of the participants, either on TB treatment (if TB was confirmed) or alternative
therapy, in participants who were not diagnosed with TB.
The isolated TB strains will be sent to the Research Center Borstel in Germany for evaluation
through sequencing and phenotypic methods. The remnants of collected samples will be stored
in the National TB Laboratory for future evaluations of new tests.
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