Biomarkers for Therapy Response in Drug-resistant Tuberculosis

• Sponsor: Research Center Borstel (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02597621
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 93
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
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

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biomarkers for Therapy Response in Drug-resistant Tuberculosis
• Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	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

1. Identification of biomarkers for therapy response [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Research Center Borstel	Borstel	Schleswig-Holstein	Germany	23845

Sponsors and Collaborators

• Research Center Borstel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Nov 5, 2015
• Last Update Posted: Sep 23, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant

Study Results

No Results Posted as of Sep 23, 2019