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NCT03507816 Clinical Trial

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

Tuberculosis Clinical Trial

Official title:
Epidemiology and Treatment of Multidrug-resistant (MDR TB) and Extensively Drug- Resistant (XDR TB) Tuberculosis in Strasbourg, France; a 10 Years Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03507816
Other study ID # 7002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2018
Est. completion date February 2020

Study information
Verified date April 2019
Source University Hospital, Strasbourg, France
Contact Xavier ARGEMI, MD
Phone 33 3 69 55 11 87
Email xavier.argemi@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 22
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Maladies Infectieuses et Tropicales Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study of clinical characteristics of patients hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis The period from January 1st, 2006 to December 31st, 2016 will be examined
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