Back to results

Improving the Diagnostic of Tuberculosis

Primary Purpose

Tuberculosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pharyngeal swab

About this trial

This is an interventional diagnostic trial for Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient taken for microbiological examinations "kit mycobacterium"
Patient Major (> 18 years).
Patient who freely signed the informed written consent.
Patient affiliated to a system of social security. Exclusion criteria
Patient minor (<18 years).
Patient pregnant or nursing.
Major Patient under guardianship.
Private Patient liberty or under court order.
Patient refusing to sign the informed consent form.

Sites / Locations

Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diagnosis of M.tuberculosis infection

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with microbiological diagnosis of M. tuberculosis infection

Secondary Outcome Measures

pulmonary tuberculosis diagnostic time.

Prevalence of diagnosed patients Beijing

Direct cost of microbiological diagnosis of extra Beijing genotype

(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.

Full Information

NCT ID

NCT02861768

First Posted

August 5, 2016

Last Updated

April 20, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT02861768

Brief Title

Improving the Diagnostic of Tuberculosis

Official Title

Improving the Diagnostic of Tuberculosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 22, 2013 (undefined)

Primary Completion Date

February 8, 2019 (Actual)

Study Completion Date

February 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis. Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal. Secondary Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely. Beijing genotype prevalence among patients with pulmonary tuberculosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

991 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diagnosis of M.tuberculosis infection

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Pharyngeal swab

Primary Outcome Measure Information:

Title

Percentage of patients with microbiological diagnosis of M. tuberculosis infection

Time Frame

3 years

Secondary Outcome Measure Information:

Title

pulmonary tuberculosis diagnostic time.

Time Frame

3years

Title

Prevalence of diagnosed patients Beijing

Time Frame

3 years

Title

Direct cost of microbiological diagnosis of extra Beijing genotype

Description

(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient taken for microbiological examinations "kit mycobacterium" Patient Major (> 18 years). Patient who freely signed the informed written consent. Patient affiliated to a system of social security. Exclusion criteria Patient minor (<18 years). Patient pregnant or nursing. Major Patient under guardianship. Private Patient liberty or under court order. Patient refusing to sign the informed consent form.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

catherine GEINDRE

Organizational Affiliation

Assistance Publique Hopitaux De Marseille

Official's Role

Study Director

Facility Information:

Facility Name

Assistance Publique Hopitaux de Marseille

City

Marseille

Country

France

12. IPD Sharing Statement

Learn more about this trial

Improving the Diagnostic of Tuberculosis

We'll reach out to this number within 24 hrs