NCT03507816

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

February 16, 2018

Last Update Submit

April 29, 2019

Conditions

Tuberculosis

Keywords

TuberculosisMulti-drug Resistant TuberculosisObservational retrospective studyClinical epidemiologyTreatment outcomeMigrantPrecarity

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with proven MDR or XDR tuberculosis

You may qualify if:

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

You may not qualify if:

  • \- Refusal of the patient to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Maladies Infectieuses et Tropicales

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

TuberculosisTuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Xavier ARGEMI, MD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Central Study Contacts

Xavier ARGEMI, MD

CONTACT

33 3 69 55 11 87xavier.argemi@chru-strasbourg.fr

Magalie Paz, MD

CONTACT

33 3 69 55 11 87magalie.paz@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

April 25, 2018

Study Start

February 23, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)