Innovation in Tuberculosis

Tuberculosis Clinical Trial

— INNOVA4TB  

Official title:

Innovation in Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04002869
• Other study ID #: 823854
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Fundació Institut Germans Trias i Pujol
• Contact: JOSE A DOMINGUEZ BENITEZ, PhD
• Phone: 34 93 497 86 97
• Email: jadominguez[@]igtp.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• Immunologic, molecular, metabolomic and radiolologic diagnostic
Evaluation and development of new technologies

Locations

Country	Name	City	State
Spain	Institut D'Investigació Germans Trias I Pujol	Badalona	Barcelona

Sponsors (12)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Sensitivity, Specificity and predictive values	01/01/2019 to 31/12/2022