TuberculosisNCT03507816
A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace
An observational study of Tuberculosis, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2018to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with proven MDR or XDR tuberculosis
Who may be able to join
- Major patient (≥18 years old)
- Patient hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis
Who cannot join
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Maladies Infectieuses et Tropicales
Strasbourg, 67091
Xavier ARGEMI, MD, 33 3 69 55 11 87, xavier.argemi@chru-strasbourg.fr
Magalie PAZ, MD, 33 3 69 55 11 87, magalie.paz@chru-strasbourg.fr
About this study
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
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.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Multi-drug Resistant Tuberculosis, Observational retrospective study, Clinical epidemiology, Treatment outcome, Migrant, Precarity
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of clinical characteristics of patients hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis
Measured: The period from January 1st, 2006 to December 31st, 2016 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start23 Feb 2018
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier ARGEMI, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507816
- Sponsor's protocol ID
- 7002
- Status last verified
- Apr 2019
- First submitted
- 16 Feb 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03507816
- Acronym / sponsor ID
- 7002
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Multi-drug Resistant Tuberculosis, Observational retrospective study, Clinical epidemiology, Treatment outcome, Migrant, Precarity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with proven MDR or XDR tuberculosis
Key inclusion criteria (2 listed)
- Major patient (≥18 years old)
- Patient hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis
Key exclusion criteria (1 listed)
- Refusal of the patient to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of clinical characteristics of patients hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis
Time frame: The period from January 1st, 2006 to December 31st, 2016 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier ARGEMI, MD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier ARGEMI, MD (33 3 69 55 11 87, xavier.argemi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of clinical characteristics of patients hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis (time frame: The period from January 1st, 2006 to December 31st, 2016 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.