Innovation in Tuberculosis (INNOVA4TB)

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.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis
• Intervention / Treatment: Diagnostic test: Immunologic, molecular, metabolomic and radiolologic diagnostic

• Study Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

• Study Contact: Name: JOSE A DOMINGUEZ BENITEZ, PhD; Phone Number: 8697 34 93 497 86 97; Email: jadominguez@igtp.cat
• Study Contact Backup: Name: BARBARA MOLINA MOYA, PhD; Phone Number: 8682 34 93 497 86 82; Email: innova4tb@igtp.cat

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut d'Investigació Germans Trias i Pujol
      • Contact: JOSE A DOMINGUEZ BENITEZ, PhD; Phone Number: 8697 34934978697; Email: jadominguez@igtp.cat
      • Contact: BARBARA MOLINA MOYA, PhD; Phone Number: 8682 34 93 497 8682; Email: innova4tb@igtp.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: Immunologic, molecular, metabolomic and radiolologic diagnostic; 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.	Diagnostic test: Immunologic, molecular, metabolomic and radiolologic diagnostic; 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	Diagnostic test: Immunologic, molecular, metabolomic and radiolologic diagnostic; 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	Diagnostic test: Immunologic, molecular, metabolomic and radiolologic diagnostic; Evaluation and development of new technologies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Sensitivity, Specificity and predictive values	01/01/2019 to 31/12/2022

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 823854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the only possibility of sharing data it will be as anonymized data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No