Innovation in Tuberculosis

NCT04002869 | Unknown DMC

• 1 other identifier: 823854
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Sensitivity, Specificity and predictive values

  01/01/2019 to 31/12/2022

Study Arms (5)

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

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

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.

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

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.

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Uninfected control

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

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

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

Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic

Interventions

Immunologic, molecular, metabolomic and radiolologic diagnostic DIAGNOSTIC_TEST

Evaluation and development of new technologies

Active TB suspicion; Latent TB infection; NTM infection; Other respiratory diseases; Uninfected control

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Briefly, subjects from different study groups will be included: (i) patients with suspicion of active TB, (ii) individuals with latent TB infection, (iii) patients with NTM infection, (iv) healthy uninfected controls, and (v) patients with other respiratory diseases such as Acute Respiratory Infections (ARIs) or lung cancer.

You may not qualify if:

• Patients who are not able to give their informed consent to participate in the study will be excluded

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Umeå University: collaborator
• North-Western State Medical University named after I.I.Mechnikov: collaborator
• INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC: collaborator
• ODESA SIGNIFICANT DISEASES CENTER: collaborator
• Vinnitsa National Medical University: collaborator
• SERVICIOS CLINICOS SA: collaborator
• Genome Identification Diagnostics GmbH: collaborator
• EMPE DIAGNOSTICS AB: collaborator
• MAGRITEK GMBH: collaborator
• Universidad de La Frontera: collaborator

Study Sites (1)

Institut D'Investigació Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

JOSE A DOMINGUEZ BENITEZ, PhD

CONTACT

34 93 497 86 97; jadominguez@igtp.cat

BARBARA MOLINA MOYA, PhD

CONTACT

34 93 497 86 82; innova4tb@igtp.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

ES (1)