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EX-­TB-Study

AcronymISRCTNEudraCTClinicaltrials.govDRKS

Identification and Evaluation of biomarkers for improved care of patients with extrapulmonary tuberculosis

Status: Active

Purpose / Objectives

Primary Outcome

- Identification of biomarkers for improved diagnostics and the assessment of a successful treatment response

- Predicting TB cure in patients suffering from extrapulmonary TB by projecting the time series of biomarker measurements, clinical outcome and radiological improvement.

- Establishment of an extrapulmonary TB clinical cohort (EX-TB-cohort)

Diagnosis

extrapulmonary TB

 

Patient attributes

Age

18-99

Inclusion criteria

- Isolation of Mycobacterium tuberculosis from a bodily secretion or tissue by

a)    microscopy

b)    PCR

c)     culture

or

a presumptive clinical diagnosis based on epidemiologic exposure together with physical findings, radiographic findings, positive interferon-gamma release assay, and/or histopathology

- Patients with extrapulmonary TB

  • Pleura
  • lymph nodes
  • bones and joints
  • CNS
  • Larynx
  • pericardial
  • parotis
  • abdominal sites
  • kidneys
  • genitourinary tract
  • disseminated (miliary) TB
  • other than pulmonary TB

- When there is pulmonary and extrapulmonary involvement, the extrapulmonary manifestation must be leading.

- Informed consent to studyparticipation 


- In patients with HIV-TB co-infection QuantiFERON test must be positive (T-cell response in the positive control is sufficient)

 

 

Exclusion criteria

 

- At baseline

  • Relevant immunosuppression at the 
physicians discretion 


  • Age <18 years 


  • Anticipated inability to follow the study requirements 


  • Patient in custodianship or guardianship 


  • Anticipated inability to finish study due to physical weakness 


- Leading pulmonary manifestation

- Patients with HIV-TB co-infection and negative QuantiFERON test

- negative QuantiFERON test

Trial design

  • Single center
  • Prospective
  • One-arm
  • Cohort

Documents (password protected)

Responsibilities in overall trial

Study Sites

Klinik I für Innere Medizin

Study office

Status

Active

Principal Investigator

Dr. med. Isabelle Suarez (geb. Kolbe)

Deputy of Principal Investigator

  • Dr. med. Jan Rybniker

Subinvestigator

  • Univ.-Prof. Dr. med. Gerd Fätkenheuer
  • Prof. Dr. med. Clara Lehmann
  • Dr. Jakob J. Malin
  • Dr. med. Vanessa Priesner (geb. Brandes)

Contact at Site