New Genomic Techniques and Management of Multidrug-resistant Tuberculosis

NCT04397536 | Unknown

• 1 other identifier: APHP190613
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multi-Drug Resistant Tuberculosis

Keywords

Tuberculosis; Multi-Drug Resistance; Diagnosis; Whole Genome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Performances (deadlines to obtain results, sensitivity, specificity) to identify the species within the tuberculosis complex, and to diagnose resistance to anti-tuberculosis drugs

  At the end enrollment

• Number of anti-tuberculosis days

  At the end enrollment

• Performances (sensitivity, specificity) of the WGS strategy by using different pipelines

  At the end enrollment

• Number of laboratory procedures

  At the end enrollment

• Costs of personal time and laboratory procedures

  At the end enrollment

Study Arms (1)

Cohort

Patients diagnosed with MDR-TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients diagnosed with MDR-TB in France during the frame time of the project

You may qualify if:

• 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

You may not qualify if:

• Patient with non MDR tuberculosis ;
• Impossibility of carrying out a phenotypic antibiogram (absence of bacterial culture, contaminated culture)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Tuberculosis; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra AUBRY, Pr

  Pitié-Salpêtrière Hospital (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra AUBRY, Pr

CONTACT

01 42 16 20 70; alexandra.aubry@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 21, 2020
• Study Start: August 29, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

FR (1)