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M/XDR-Biomarker

AcronymISRCTNEudraCTClinicaltrials.govDRKS
M/XDR-BiomarkerNCT02597621

Identification of Biomarkers for multidrug-resistant (MDR) tuberculosis therapy response assessment

Status: Active

Purpose / Objectives

Primary Outcome

1. Predicting TB cure in the M/XDR-TB patients by projecting the time series of biomarker measurements, clinical scores, and radiological improvement in the pan sensitive TB group to the timeline of the M/XDR-TB patients.

2. Description of the longitudinal data of biomarker measurements, clinical scores, and radiological improvement in the cohort arm of patients with pan sensitive TB and in the cohort arm of patients with M/XDR-TB.

3. Correlation of biomarker measurements with clinical scores and radiological improvement at different time points (baseline, SC, CC, and in pan sensitive TB also cure).

4. Comparison of the longitudinal data in the two cohort arms.

 

Diagnosis

1. M/XDR-cohort: patients with a suspected infection with an M/XDR-TB strain on behalf of molecular biological methods; TB infection confirmed by culture

2. non M/XDR-cohort: patients with no suspected infection with an M/XDR-TB strain on behalf of molecular biological methods; TB infection confirmed by culture

3. control cohort: healthy subjects and subjects with other lung diseases than tuberculosis

Patient attributes

Stage

Infection with Tuberculosis

Age

18-99

Inclusion criteria

  • Patients with acid fast bacilli sputum smear positive tuberculosis, identified by

a) sputum smear microscopy

b) M. tuberculosis specific nucleic acid amplification testing on Sputum

 

  • Molecular identification of rifampicin drug resistance of M. tuberculosis in Sputum
  • Informed consent to study participation

Exclusion criteria

At baseline

  • Tuberculosis therapy within the last 6 months
  • HIV infection
  • 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
  • Inability to finish the study due to anticipated migration

After baseline:

• Drug sensitivity testing unavailable

Trial design

  • Multicenter
  • Prospective
  • Three-arm

Intervention

Tuberculosis therapy and therapy for other diseases will be given according to WHO treatment guidelines, the clinical judgement of the attending physician. The study participation has no impact on the treatment of the patient’s disease. Drugs and treatment times are recorded in the case record forms.

Documents (password protected)

Responsibilities in overall trial

Forschungszentrum Borstel

  • Tel. 04537/188-0
  • Fax 04537/188-2440

National Coordinating Investigator

Prof. Christoph Lange

Study Sites

Klinik I für Innere Medizin

Status

Active

Principal Investigator

Dr. med. Jan Rybniker

Deputy of Principal Investigator

  • Dr. med. Isabelle Suarez (geb. Kolbe)

Subinvestigator

  • Marianne Breuninger

Contact at Site