TuBerculosis Viability Interregional Study and Agreement on Biological Tests

NCT04968886 | Unknown

• 1 other identifier: APHP180578
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to confirm in a multicentric study the utility of our viability test in large cohort of smear-positive pulmonary tuberculosis patients under treatment and to determine if the test could help physicians to discontinue isolation measures in hospital setting.

Conditions

Tuberculosis, Pulmonary

Keywords

Hospital infection control; Isolation; Treatment response; Tuberculosis; Viability stain

Outcome Measures

Primary Outcomes (1)

• Result of the viability test (positive or negative) compared to culture results (reference test). - The reference test will be considered as positive (C+) if Mtb are grown on solid or liquid media et negative (C-) if the cultures remain sterile after 42

  The culture will be judged positive in case of isolation of tubercle bacilli in solid or liquid medium and will be judged negative if the culture is sterile after 42 days of incubation in liquid medium and 60 days in solid medium. If the culture is contaminated with bacteria other than tubercle bacilli, it will be considered uninterpretable. \- The microscopic viability test will be judged positive in the event of observation of at least 1 bacillus per slide is stained with Syto9 in fluorescent green per slide on microscopic examination of the smear and will be judged negative if no bacillus fluoresces in green . Each test will be interpreted blind to the results of the other and the results of the TVmol. the diagnostic indices of the microscopic viability test will be calculated

  12 months

Secondary Outcomes (4)

• Evaluate the diagnostic performance of the molecular test for the viability of tuberculosis bacilli

  12 months

• Study the correlation between the quantitative results of viability tests and the quantitative results of the culture

  12 months

• Evaluate the potential benefit of viability tests for the patient and the hospital over the duration of isolation and the time to discharge from hospital

  12 months

• Describe the cohort of patients hospitalized for pulmonary tuberculosis with positive microscopic examination in the 10 participating centers

  12 months

Interventions

Diagnostic Test: viability test on sputum and comparision with culture results (reference test) DIAGNOSTIC_TEST

Diagnostic Test: viability test on sputum and comparision with culture results (reference test)

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

Smear-positive pulmonary tuberculosis patients.

You may qualify if:

• Age from 18 years old
• Patient put on anti-tuberculosis treatment for pulmonary tuberculosis with at least one positive ME
• Information given on the study and the right to oppose

You may not qualify if:

• Refusal of participation
• People unable to understand the information, In accordance with article 11218 of the public health code,
• people not affiliated with Health Insurance,
• pregnant or breastfeeding women patients under legal protection can be included in a non-interventional study (type 3).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Benjamin WYPLOSZ, Ph

  Public Assistance of Paris Hospitals (APHP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin WYPLOSZ, Ph

CONTACT

01 45 21 74 25; benjamin.wyplosz@aphp.fr

Emmanuelle CAMBAU, Ph

CONTACT

01 40 25 80 35; emmanuelle.cambau@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06