Biomarkers for Therapy Response in Drug-resistant Tuberculosis
1 other identifier
observational
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedApril 11, 2024
April 1, 2024
7.8 years
November 3, 2015
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of biomarkers for therapy response
3 years
Study Arms (3)
M/XDR
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
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
Healthy controls.
Interventions
Eligibility Criteria
Patients with microbiologically confirmed pulmonary MDR-TB
You may qualify if:
- Subjects with confirmed pulmonary MDR-TB
- Subject able and willing to give informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Center Borstel
Borstel, Schleswig-Holstein, 23845, Germany
Related Publications (1)
Heyckendorf J, Marwitz S, Reimann M, Avsar K, DiNardo AR, Gunther G, Hoelscher M, Ibraim E, Kalsdorf B, Kaufmann SHE, Kontsevaya I, van Leth F, Mandalakas AM, Maurer FP, Muller M, Nitschkowski D, Olaru ID, Popa C, Rachow A, Rolling T, Rybniker J, Salzer HJF, Sanchez-Carballo P, Schuhmann M, Schaub D, Spinu V, Suarez I, Terhalle E, Unnewehr M, Weiner J 3rd, Goldmann T, Lange C. Prediction of anti-tuberculosis treatment duration based on a 22-gene transcriptomic model. Eur Respir J. 2021 Sep 2;58(3):2003492. doi: 10.1183/13993003.03492-2020. Print 2021 Sep.
PMID: 33574078DERIVED
Biospecimen
Urine, blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of International Health / Infectious Diseases, University Lübeck
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 5, 2015
Study Start
March 1, 2013
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
April 11, 2024
Record last verified: 2024-04