Multi-Drug Resistant Tuberculosis Clinical Trial
— GENO-MDROfficial title:
Impact of New Genomic Tools on the Management of Patients With Multidrug-resistant Tuberculosis
In the context of the emergence of cases of multidrug-resistant tuberculosis (MDR-TB) it is crucial to improve patient's management. Therefore, assessing the place of innovative strategies enabling the diagnosis of those cases (e.g. WGS and Deeplex-MycTB) in the personalized care of patients with MDR-TB and the rationalization of medical biology procedures is a major issue. This project participates to these goals since the investigators will : (i) assess the diagnostic qualities and the performance of the different innovatives strategies enabling detection of resistance to anti-tuberculosis drugs, (ii) assess the impact of these strategies in the implementation of personalized treatments for MDR-TB patients, and (iii) assess the overall costs of these strategies.
Status | Recruiting |
Enrollment | 172 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age = 18 years ; - patient with bacteriologically proven tuberculosis due to a multidrug resistance strain (i.e. resistant to rifampin and isoniazid) - patient informed of the study and not opposed to participating in the research Exclusion Criteria: - Patient with non MDR tuberculosis ; - Impossibility of carrying out a phenotypic antibiogram (absence of bacterial culture, contaminated culture) |
Country | Name | City | State |
---|---|---|---|
France | Pitié Salpêtrière Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity for the detection of bedaquiline resistance | The sensitivity of WGS-based strategies will be compared to phenotypic strategy for the detection of bedaquiline's resistance | At the end enrollment | |
Secondary | Performances (deadlines to obtain results, sensitivity, specificity) to identify the species within the tuberculosis complex, and to diagnose resistance to anti-tuberculosis drugs | Comparison of the performances (deadlines to obtain results, sensitivity, specificity) of WGS and Deeplex-MycTB strategies compared to the performances of the phenotypic reference method, to identify the species within the tuberculosis complex, and to diagnose resistance to anti-tuberculosis drugs from bacterial cultures and directly from positive samples on microscopic examination | At the end enrollment | |
Secondary | Number of anti-tuberculosis days | Comparison of the number of anti-tuberculosis days that would have been prescribed by excess or by error between the date when the genotypic drug susceptibility testing results are available and the reception of the sample or strain for each of the strategies, and the date when the final drug susceptibility results are available (i.e. those obtained with the phenotypic method which is the reference method) | At the end enrollment | |
Secondary | Performances (sensitivity, specificity) of the WGS strategy by using different pipelines | The sensitivity and the specificity of the WGS results analysed with different pipeline ((BioNumerics, TB-Profiler, PhyResSe) as well as CNR-MyrMA own pipeline) will be compared to the drug susceptibility testing result of the phenotypic method, which is the reference method | At the end enrollment | |
Secondary | Number of laboratory procedures | Number of laboratory procedures performed for WGS and Deeplex-MycTB strategies compared to the number of procedures performed for the current genotypic strategy used at the CNR-MyrMA | At the end enrollment | |
Secondary | Costs of personal time and laboratory procedures | Costs of personal time (medical and non-medical) and laboratory procedures required for WGS and Deeplex-MycTB strategies compared to costs of personal time and laboratory procedures required for the genotypic methods used at CNR-MyrMA | At the end enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03057756 -
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
|
||
Completed |
NCT04207112 -
Economic Evaluation of New MDR TB Regimens
|
Phase 2/Phase 3 | |
Completed |
NCT03000517 -
PK of Levofloxacin in MDR-TB Patients
|
N/A | |
Completed |
NCT03470233 -
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
|
||
Completed |
NCT03830671 -
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
|
Phase 4 | |
Withdrawn |
NCT01600963 -
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
|
Phase 3 | |
Recruiting |
NCT03575299 -
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
|
Phase 1 | |
Recruiting |
NCT03827811 -
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
|
||
Completed |
NCT04342598 -
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
|
||
Completed |
NCT04309656 -
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
|
Phase 1 | |
Completed |
NCT03822156 -
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
|
||
Completed |
NCT00425113 -
Metronidazole for Pulmonary Tuberculosis (South Korea)
|
Phase 2 | |
Active, not recruiting |
NCT04081077 -
PRACTECAL-PKPD Sub Study
|
Phase 2/Phase 3 | |
Completed |
NCT00664313 -
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
|
Phase 1/Phase 2 | |
Completed |
NCT00691392 -
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
|
Phase 1/Phase 2 |