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Biomarkers for Therapy Response in Drug-resistant Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

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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

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




Primary Outcome Measures :
  1. Identification of biomarkers for therapy response [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Urine, blood


Information from the National Library of Medicine

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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.

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