Biomarkers for Therapy Response in Drug-resistant Tuberculosis

April 9, 2024 updated by: Christoph Lange, Research Center Borstel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with microbiologically confirmed pulmonary MDR-TB

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of biomarkers for therapy response
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Center Borstel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimated)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M/XDR_BIO_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tuberculosis, Multidrug-resistant

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe