Biomarkers for Therapy Response in Drug-resistant Tuberculosis

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ClinicalTrials.gov Identifier: NCT02597621

Recruitment Status : Unknown

Verified September 2019 by Christoph Lange, Research Center Borstel.
Recruitment status was: Active, not recruiting

First Posted : November 5, 2015

Last Update Posted : September 23, 2019

Sponsor:

Information provided by (Responsible Party):

Christoph Lange, Research Center Borstel

Study Description

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.

Condition or disease	Intervention/treatment
Tuberculosis, Multidrug-resistant	Other: no intervention

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).

Study Design

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Study Type :	Observational
Estimated Enrollment :	40 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Biomarkers for Therapy Response in Drug-resistant Tuberculosis
Study Start Date :	March 2013
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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	Other: no intervention no intervention
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.	Other: no intervention no intervention
Healthy Controls Healthy controls.	Other: no intervention no intervention

Outcome Measures

Primary Outcome Measures :

Identification of biomarkers for therapy response [ Time Frame: 3 years ]

Biospecimen Retention: Samples With DNA

Urine, blood

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with microbiologically confirmed pulmonary MDR-TB

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597621

Locations

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Germany
Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845

Sponsors and Collaborators

Research Center Borstel

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heyckendorf J, Marwitz S, Reimann M, Avsar K, DiNardo AR, Günther G, Hoelscher M, Ibraim E, Kalsdorf B, Kaufmann SHE, Kontsevaya I, van Leth F, Mandalakas AM, Maurer FP, Müller M, Nitschkowski D, Olaru ID, Popa C, Rachow A, Rolling T, Rybniker J, Salzer HJF, Sanchez-Carballo P, Schuhmann M, Schaub D, Spinu V, Suárez 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). pii: 2003492. doi: 10.1183/13993003.03492-2020. Print 2021 Sep.

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Responsible Party:	Christoph Lange, Head of International Health / Infectious Diseases, University Lübeck, Research Center Borstel
ClinicalTrials.gov Identifier:	NCT02597621
Other Study ID Numbers:	M/XDR_BIO_01
First Posted:	November 5, 2015 Key Record Dates
Last Update Posted:	September 23, 2019
Last Verified:	September 2019

Additional relevant MeSH terms:

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Tuberculosis Tuberculosis, Multidrug-Resistant Mycobacterium Infections Actinomycetales Infections	Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections

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