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Innovation in Tuberculosis

Innovation in Tuberculosis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04002869
Acronym
INNOVA4TB
Enrollment
550
Registered
2019-07-01
Start date
2019-01-01
Completion date
2022-12-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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.

Interventions

DIAGNOSTIC_TESTImmunologic, molecular, metabolomic and radiolologic diagnostic

Evaluation and development of new technologies

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy01/01/2019 to 31/12/2022Sensitivity, Specificity and predictive values

Countries

Spain

Contacts

Primary ContactJOSE A DOMINGUEZ BENITEZ, PhD
jadominguez@igtp.cat34 93 497 86 97
Backup ContactBARBARA MOLINA MOYA, PhD
innova4tb@igtp.cat34 93 497 86 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026