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Completed

NCT Number: NCT02597621

Biomarkers for Therapy Response in Drug-resistant Tuberculosis

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.

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Key information

Conditions

Tuberculosis, Multidrug-Resistant Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Identification of biomarkers for therapy response

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Registry information

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Nov 5, 2015
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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