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

March 6, 2018 updated by: Michael Hoelscher

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 050159
        • Marius Nasta Pulmonology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 70 days after enrolment
Up to 70 days after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Hoelscher

Collaborators

"Marius Nasta" Pulmonology Institute
Clinical Infectious Diseases Research Center Borstel, Germany

Investigators

  • Principal Investigator: Elmira Ibraim, MD, Marius Nasta Pulmonology Institute, Sos. Viilor 90 Sector 5, 050159 Bucharest, Romania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMU-IMPH-Bucharest-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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