Time-to-Detection in Culture of Mycobacterium Tuberculosis | NCT05568368

Studies
Time-to-Detection in Culture of Mycobacterium Tuberculosis

NCT05568368

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Oct 5, 2022Actual

Enrollment

705Actual

Phase

Not provided

Conditions

Pulmonary Tuberculoses

Interventions

No intervention

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

Status Module

Record Verification Date

Oct 2022

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 15, 2022Actual

Primary Completion Date

Sep 15, 2022Actual

Completion Date

Sep 15, 2022Actual

First Submitted Date

Oct 4, 2022

First Submission Date that Met QC Criteria

Oct 4, 2022

First Posted Date

Oct 5, 2022Actual

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

Oct 4, 2022

Last Update Posted Date

Oct 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

705Actual

Label	Type	Description	Intervention Names
Index cases			Other: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	no intervention	Index cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tuberculosis transmission	duration of Tuberculosis transmission between an infected person and a contact case	2 months
contact case tracking	screening time for contact cases	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have at least 1 contact case explored for tuberculosis
latent tuberculosis infection

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

94 Years

Standard Ages

ChildAdultOlder Adult

Study Population

all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of bacteriology of Nice University Hospital, and that was positive in culture before treatment and of which contact cases were explored by the CLAT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nice University Hospital		Nice		06000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014397	Tuberculosis, Pulmonary

Ancestor Terms

ID	Term
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided