- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02382107
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).
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Bucharest, Romania, 050159
- Marius Nasta Pulmonology Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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
Lasso di tempo: Up to 70 days after enrolment
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Up to 70 days after enrolment
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Elmira Ibraim, MD, Marius Nasta Pulmonology Institute, Sos. Viilor 90 Sector 5, 050159 Bucharest, Romania
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LMU-IMPH-Bucharest-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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