Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02597621
  4. Details
NCT02597621 Clinical Trial

Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Tuberculosis, Multidrug-resistant Clinical Trial

Official title:
Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02597621
Other study ID # M/XDR_BIO_01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2013
Est. completion date January 2021

Study information
Verified date April 2024
Source Research Center Borstel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 192
Est. completion date January 2021
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
Germany Research Center Borstel Borstel Schleswig-Holstein

Sponsors (1)
Lead Sponsor Collaborator
Research Center Borstel

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of biomarkers for therapy response 3 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05871489 - Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Active, not recruiting NCT04179500 - A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers Phase 2
Completed NCT03086486 - Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis Phase 3
Completed NCT01201941 - Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru N/A
Not yet recruiting NCT06441006 - Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis Phase 3
Completed NCT03303963 - DIAgnostics for Multidrug Resistant Tuberculosis in Africa
Completed NCT02413931 - Nosocomial Transmission of MDR-TB in Bucharest, Romania
Recruiting NCT05306223 - A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China Phase 4
Completed NCT02573350 - A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 Phase 2
Recruiting NCT05555303 - Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis Phase 2
Recruiting NCT03828201 - Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB Phase 2
Recruiting NCT01212003 - Training Protocol on the Natural History of Tuberculosis
Terminated NCT03237182 - The Individualized M(X) Drug-resistant TB Treatment Strategy Study Phase 4
Completed NCT03338621 - Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients Phase 2/Phase 3
Not yet recruiting NCT05007795 - Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis N/A
Completed NCT03728725 - Xpert MTB/XDR Clinical Evaluation Trial
Completed NCT02589782 - Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) Phase 2/Phase 3
Recruiting NCT02619994 - Treatment Shortening of MDR-TB Using Existing and New Drugs Phase 2
Completed NCT01918397 - Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB Phase 2

External Links