Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Research Center Borstel

Status: Completed

Conditions: Tuberculosis, Multidrug-resistant

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02597621

M/XDR_BIO_01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

192 participants in 3 patient groups

M/XDR

Description:

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

Treatment:

Other: no intervention

Susceptible

Description:

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.

Treatment:

Other: no intervention

Healthy Controls

Description:

Healthy controls.

Treatment:

Other: no intervention