A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace

NCT ID: NCT03507816

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-23

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tuberculosis Multi-drug Resistant Tuberculosis Observational retrospective study Clinical epidemiology Treatment outcome Migrant Precarity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major patient (≥18 years old)
* Patient hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis

Exclusion Criteria

\- Refusal of the patient to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xavier ARGEMI, MD

Role: STUDY_DIRECTOR

University Hospital, Strasbourg, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service de Maladies Infectieuses et Tropicales

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xavier ARGEMI, MD

Role: CONTACT

Phone: 33 3 69 55 11 87

Email: [email protected]

Magalie Paz, MD

Role: CONTACT

Phone: 33 3 69 55 11 87

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xavier ARGEMI, MD

Role: primary

Magalie PAZ, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7002

Identifier Type: -

Identifier Source: org_study_id