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
Verified date | March 2018 |
Source | Ludwig-Maximilians - University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 400 |
Est. completion date | August 2017 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with suspected pulmonary TB, who have a chest radiograph which is compatible with pulmonary TB plus one of the signs or symptoms listed below and indicative of possible TB: - Productive cough for more than 2 weeks - Haemoptysis - Fever - Night sweats - Substantial involuntary weight loss - Subject able and willing to give informed consent, including for HIV-testing Exclusion Criteria: - anti-tuberculosis therapy with simultaneous administration of at least 2 active compounds taken currently or within the previous 6 months - physical or mental inability preventing study participation as determined at the discretion of the investigator - member of a vulnerable population group (prisoner, soldier, mental illness, under guardianship, age <18 years) - extrapulmonary tuberculosis without pulmonary involvement - incapability to produce 2 sputum samples of sufficient quality (mucoid) and volume (at least 3ml) |
Country | Name | City | State |
---|---|---|---|
Romania | Marius Nasta Pulmonology Institute | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Michael Hoelscher | Clinical Infectious Diseases Research Center Borstel, Germany, Marius Nasta Pulmonology Institute, Bucharest, Rumania |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main objective is the evaluation of the diagnostic characteristics (sensitivity, specificity) of several new rapid diagnostic tests for TB compared to culture (both liquid and solid) as the reference standard in patients | Up to 70 days after enrolment |
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