Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
French National Cohort of Patients With Rifampicin-Resistant Tuberculosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
French National Cohort of Patients With Rifampicin-Resistant Tuberculosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTRol-TB
Brief Summary:
A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment In 2021 only 60 of patients with MDRRR tuberculosis who received treatment globally were successfully cured while 12 succumbed to the disease and 10 experienced treatment failure
In France a recent study by the National Reference Centre for Mycobacteria showed that while MDRRR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68 of cases 30 were lost The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli as well as the factors influencing these outcomes Additionally it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France
A national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020 with planned inclusions until 2029 The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024 As for the prospective cohort arm a projected total of roughly 300 patients will be included over the period from 2020 to 2029 Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France national register for the prospective cohorte For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria
Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator Statistical analyses will include descriptive analyses of continuous and categorical variables comparisons between subgroups using appropriate tests Students t Mann-Whitney Chi Square Fisher and logistic regressions to identify variables associated with treatment outcomes P value 005 will be considered statistically significant
In France a recent study by the National Reference Centre for Mycobacteria showed that while MDRRR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68 of cases 30 were lost The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli as well as the factors influencing these outcomes Additionally it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France
A national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020 with planned inclusions until 2029 The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024 As for the prospective cohort arm a projected total of roughly 300 patients will be included over the period from 2020 to 2029 Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France national register for the prospective cohorte For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria
Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator Statistical analyses will include descriptive analyses of continuous and categorical variables comparisons between subgroups using appropriate tests Students t Mann-Whitney Chi Square Fisher and logistic regressions to identify variables associated with treatment outcomes P value 005 will be considered statistically significant
Detailed Description:
Tuberculosis TB is a major global health problem Over the past decade Mycobacterium tuberculosis has killed more people worldwide than any other infectious pathogen and drug-resistant TB accounts for a third of deaths linked to antimicrobial resistance AMR A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment In 2021 only 60 of patients with MDRRR tuberculosis who received treatment globally were successfully cured while 12 succumbed to the disease and 10 experienced treatment failure In France a recent study by the National Reference Centre for Mycobacteria showed that while MDRRR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68 of cases 30 were lost
In a context of low incidence and loss of expertise in the management of MDRRR tuberculosis in Western Europe and France the creation of a national retrospective and prospective cohort will make it possible to measure the treatment outcomes of these patients a vital indicator for assessing the quality of careThe main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli as well as the factors influencing these outcomes Additionally it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France
This is a national longitudinal cohort which includes a historical retrospective part 2006-2019 and a prospective part developed with the setting up of the CNR national register of Mycobacteria from 2020 planned inclusions until 2029 The population in the restrospective cohort includes 298 patients in the period 2006-2019 and 178 included in the national registry of the CNR mycobacteria national registry till end of May 2024 As for the prospective cohort arm a projected total of roughly 300 patients will be incorporated over the period from 2020 to 2029 Non-identifying clinical data for the restrospective cohorte will be exclusively derived from the medical records of patients in the investigating departments of the 3 expert centres for multidrug-resistant tuberculosis in the Paris region Hôpitaux de la Pitié-Salpêtrière Bichat and Bligny Each centre will transcribe its own pseudonymised clinical data into a secure Excel file which will then be transmitted via Dispose AP-HP to the coordinating investigator and stored on a secure computer at the CNR of Mycobactéria
For the prospective cohort the non-identifying clinical data will be entered directly by patient referral departments into the CNR des Mycobactéries national register on a secure platform developed specifically for the register and managed by the CNR of Mycobactéria Any department in charge of patients with multidrug-resistant tuberculosis in France will be able to take part in prospective inclusion in the register
Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator Statistical analyses will include descriptive analyses of continuous and categorical variables comparisons between subgroups using appropriate tests Students t Mann-Whitney Chi Square Fisher and logistic regressions to identify variables associated with treatment outcomes P value 005 will be considered statistically significant
In a context of low incidence and loss of expertise in the management of MDRRR tuberculosis in Western Europe and France the creation of a national retrospective and prospective cohort will make it possible to measure the treatment outcomes of these patients a vital indicator for assessing the quality of careThe main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli as well as the factors influencing these outcomes Additionally it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France
This is a national longitudinal cohort which includes a historical retrospective part 2006-2019 and a prospective part developed with the setting up of the CNR national register of Mycobacteria from 2020 planned inclusions until 2029 The population in the restrospective cohort includes 298 patients in the period 2006-2019 and 178 included in the national registry of the CNR mycobacteria national registry till end of May 2024 As for the prospective cohort arm a projected total of roughly 300 patients will be incorporated over the period from 2020 to 2029 Non-identifying clinical data for the restrospective cohorte will be exclusively derived from the medical records of patients in the investigating departments of the 3 expert centres for multidrug-resistant tuberculosis in the Paris region Hôpitaux de la Pitié-Salpêtrière Bichat and Bligny Each centre will transcribe its own pseudonymised clinical data into a secure Excel file which will then be transmitted via Dispose AP-HP to the coordinating investigator and stored on a secure computer at the CNR of Mycobactéria
For the prospective cohort the non-identifying clinical data will be entered directly by patient referral departments into the CNR des Mycobactéries national register on a secure platform developed specifically for the register and managed by the CNR of Mycobactéria Any department in charge of patients with multidrug-resistant tuberculosis in France will be able to take part in prospective inclusion in the register
Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator Statistical analyses will include descriptive analyses of continuous and categorical variables comparisons between subgroups using appropriate tests Students t Mann-Whitney Chi Square Fisher and logistic regressions to identify variables associated with treatment outcomes P value 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None