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

NCT02382107 | Completed DMC

• 1 other identifier: LMU-IMPH-Bucharest-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Tuberculosis

Keywords

TB; Tuberculosis; Diagnostic study

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Observational OTHER

TB suspects, who present themselves to the pulmonary ambulance at the Marius Nasta Instiute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TB suspects who presented themselves to the pumonology ambulatory at the Marius Nasta Institute

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael Hoelscher: lead
• "Marius Nasta" Pulmonology Institute: collaborator
• Clinical Infectious Diseases Research Center Borstel, Germany: collaborator

Study Sites (1)

Marius Nasta Pulmonology Institute

Bucharest, 050159, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, sputum

MeSH Terms

Conditions

Tuberculosis; Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Elmira Ibraim, MD

  Marius Nasta Pulmonology Institute, Sos. Viilor 90 Sector 5, 050159 Bucharest, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

RO (1)