Performance of IGRAs for TB Infection Diagnosis in Elderly | NCT01895582

Studies
Performance of IGRAs for TB Infection Diagnosis in Elderly

NCT01895582

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

May 28, 2021Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Ageing
Tuberculosis

Interventions

Blood samples

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-A00326-37	Other Identifier	ANSM

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment of participants

Expanded Access Info

Start Date

Jul 17, 2013Actual

Primary Completion Date

Mar 17, 2019Actual

Completion Date

Mar 17, 2019Actual

First Submitted Date

Jun 27, 2013

First Submission Date that Met QC Criteria

Jul 5, 2013

First Posted Date

Jul 10, 2013Estimated

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

May 27, 2021

Last Update Posted Date

May 28, 2021Actual

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

Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.

TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

Detailed Description

In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.

Principal outcome:

- 3 tests performance for active TB diagnosis in patients older than 75 years-old

Secondary outcomes :

concordance between IGRAs.
non-concordant results analysis
concordance of IGRAs results with time of TB-infection
biobank

Methodology :Diagnostic test performance study

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

Retention

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Active TB-infected patients	TB-infected patients with bacteriological and histological evidences	Other: Blood samples
Non active TB-infected patients (already met TB)	some of elders have already met M tuberculosis before active antibiotherapy exists	Other: Blood samples
Non active TB-infected patients (other diagnosis)	same symptoms than two others groups but an other diagnosis	Other: Blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Other	4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml)	Active TB-infected patients Non active TB-infected patients (already met TB)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of positive, indeterminate, negative tests in each group		month27

Secondary Outcomes

Measure	Description	Time Frame
Test results in clinical LTBI patients		month 27
Correlation with TB-infection date	Test results (positive/negative) according to LTBI date	month 27

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 75 years
Consent signed
hospitalized patient with start treatment of Tuberculosis disease
French social right

Exclusion Criteria:

Tuberculosis disease treatment since 7 days
No 3 months follow-up possible
Immunosuppression

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with suspected tuberculosis disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guislaine CARCELAIN, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de médecine interne		Bondy		93143	France
Servive de Médecine Interne (Pr S. Herson)

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

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided