Innovation in Tuberculosis

NCT ID: NCT04002869

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-31

Brief Summary

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Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.

INNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active TB suspicion

This study will include both adults and children with suspicion of different degrees of severity of active TB (pulmonary and extrapulmonary) to bring the investigator's study population into line with the routine clinical practice and to avoid the spectrum bias

Immunologic, molecular, metabolomic and radiolologic diagnostic

Intervention Type DIAGNOSTIC_TEST

Evaluation and development of new technologies

Latent TB infection

Individuals with latent TB infection (adults and children), with positive TST and/or IGRAs; without any sign or radiological evidence of TB disease or any clinical picture compatible with the criteria defined in the section TB cases.

Immunologic, molecular, metabolomic and radiolologic diagnostic

Intervention Type DIAGNOSTIC_TEST

Evaluation and development of new technologies

NTM infection

Adult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation.

Immunologic, molecular, metabolomic and radiolologic diagnostic

Intervention Type DIAGNOSTIC_TEST

Evaluation and development of new technologies

Uninfected control

Both adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs

Immunologic, molecular, metabolomic and radiolologic diagnostic

Intervention Type DIAGNOSTIC_TEST

Evaluation and development of new technologies

Other respiratory diseases

Subjects with ARIs, and subjects with lung cancer; without any clinical picture compatible with the criteria defined in TB cases section. Patients with ARIs will be identified as individuals with clinical signs, symptoms and radiology of respiratory infections, and microbiological confirmation of non-TB origin. Patients with lung cancer will be identified as those with a high clinical suspicion, a suggestive chest X-ray/computed tomography scan, and a confirmed histopathological/cytological diagnosis

Immunologic, molecular, metabolomic and radiolologic diagnostic

Intervention Type DIAGNOSTIC_TEST

Evaluation and development of new technologies

Interventions

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Immunologic, molecular, metabolomic and radiolologic diagnostic

Evaluation and development of new technologies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Immunosuppression will not be considered an exclusion criterion

Exclusion Criteria

* Patients who are not able to give their informed consent to participate in the study will be excluded
Minimum Eligible Age

1 Month

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role collaborator

North-Western State Medical University named after I.I.Mechnikov

OTHER

Sponsor Role collaborator

INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC

UNKNOWN

Sponsor Role collaborator

ODESA SIGNIFICANT DISEASES CENTER

UNKNOWN

Sponsor Role collaborator

Vinnitsa National Medical University

OTHER

Sponsor Role collaborator

SERVICIOS CLINICOS SA

UNKNOWN

Sponsor Role collaborator

Genome Identification Diagnostics GmbH

UNKNOWN

Sponsor Role collaborator

EMPE DIAGNOSTICS AB

UNKNOWN

Sponsor Role collaborator

MAGRITEK GMBH

UNKNOWN

Sponsor Role collaborator

Universidad de La Frontera

OTHER

Sponsor Role collaborator

Fundació Institut Germans Trias i Pujol

OTHER

Sponsor Role lead

Responsible Party

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Jose Antonio Dominguez Benitez

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institut D'Investigació Germans Trias I Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JOSE A DOMINGUEZ BENITEZ, PhD

Role: CONTACT

34 93 497 86 97 ext. 8697

BARBARA MOLINA MOYA, PhD

Role: CONTACT

34 93 497 86 82 ext. 8682

Facility Contacts

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JOSE A DOMINGUEZ BENITEZ, PhD

Role: primary

34934978697 ext. 8697

BARBARA MOLINA MOYA, PhD

Role: backup

34 93 497 8682 ext. 8682

Other Identifiers

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823854

Identifier Type: -

Identifier Source: org_study_id

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