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NCT02597621 Clinical Trial

Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Tuberculosis, Multidrug-resistant Clinical Trial

Official title:
Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02597621
Other study ID # M/XDR_BIO_01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date January 2021

Study information
Verified date April 2024
Source Research Center Borstel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany. The aim the study is the identification of biomarkers for therapy response.

Description:

The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great concern. The current study that will be conducted at different centers in Germany. Biomarkers for treatment response during the course of the tuberculosis therapy will be evaluated. The study will be conducted with funding of the German Center for Infection Research (DZIF).

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date January 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects with confirmed pulmonary MDR-TB - Subject able and willing to give informed consent Exclusion Criteria: - HIV infection - physical or mental inability preventing study participation at the discretion of the investigator - member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship) - age <18 years.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
Germany Research Center Borstel Borstel Schleswig-Holstein

Sponsors (1)
Lead Sponsor Collaborator
Research Center Borstel

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of biomarkers for therapy response 3 years
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