Improving the Diagnostic of Tuberculosis | NCT02861768

Studies
Improving the Diagnostic of Tuberculosis

NCT02861768

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Apr 21, 2023Actual

Enrollment

991Actual

Phase

Not Applicable

Conditions

Tuberculosis

Interventions

Pharyngeal swab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A01598-35	Registry Identifier	ansm

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2013

Primary Completion Date

Feb 8, 2019Actual

Completion Date

Feb 8, 2019Actual

First Submitted Date

Aug 5, 2016

First Submission Date that Met QC Criteria

Aug 9, 2016

First Posted Date

Aug 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

991Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diagnosis of M.tuberculosis infection	Experimental		Biological: Pharyngeal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharyngeal swab	Biological		diagnosis of M.tuberculosis infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with microbiological diagnosis of M. tuberculosis infection		3 years

Secondary Outcomes

Measure	Description	Time Frame
pulmonary tuberculosis diagnostic time.		3years
Prevalence of diagnosed patients Beijing		3 years
Direct cost of microbiological diagnosis of extra Beijing genotype

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
catherine GEINDRE	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille			France

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided