Biomarkers for Therapy Response in Drug-resistant Tuberculosis
Completed
- Conditions
- Tuberculosis, Multidrug-resistant
- Interventions
- Other: no intervention
- Registration Number
- NCT02597621
- Lead Sponsor
- Research Center Borstel
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description M/XDR no intervention The M/XDR-cohort will consist of patients with a suspected infection with an M/XDR-TB strain.The suspicion will be held on behalf of molecular biological methods (i.e. GeneXpert, detection of rifampicin resistance with high probability of simultaneous isoniazid resistance). The suspected cases will be confirmed by culture (n= 20). Empirically, less than 10% of the cases have an XDR-TB Susceptible no intervention The non M/XDR-TB cohort will consist of patients with no suspected infection with an M/XDRTB strain. The suspicion will be out ruled on behalf of molecular biological methods (i.e.GeneXpert, detection of rifampicin resistance with high probability of simultaneous isoniazid resistance). The non M/XDR-TB cases will be confirmed by culture (n= 20). Empirically, about 90% of these patients have no drug resistance against first line drugs. Healthy Controls no intervention Healthy controls.
- Primary Outcome Measures
Name Time Method Identification of biomarkers for therapy response 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Center Borstel
🇩🇪Borstel, Schleswig-Holstein, Germany