TuberculosisINNOVA4TBNCT04002869
Innovation in Tuberculosis
An observational study of Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 1 month to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Immunologic, molecular, metabolomic and radiolologic diagnostic
- How many people
- 550 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Immunosuppression will not be considered an exclusion criterion
Who cannot join
- Patients who are not able to give their informed consent to participate in the study will be excluded
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut D'Investigació Germans Trias I Pujol
Badalona, Barcelona, 08916
JOSE A DOMINGUEZ BENITEZ, PhD, 34934978697 ext. 8697, jadominguez@igtp.cat
BARBARA MOLINA MOYA, PhD, 34 93 497 8682 ext. 8682, innova4tb@igtp.cat
About this study
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
- Being tested
- Immunologic, molecular, metabolomic and radiolologic diagnostic
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunologic, molecular, metabolomic and radiolologic diagnosticDiagnostic test
Evaluation and development of new technologies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Sensitivity, Specificity and predictive values
Measured: 01/01/2019 to 31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Umeå University, North-Western State Medical University named after I.I.Mechnikov, INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC, ODESA SIGNIFICANT DISEASES CENTER, Vinnitsa National Medical University, SERVICIOS CLINICOS SA, Genome Identification Diagnostics GmbH, EMPE DIAGNOSTICS AB, MAGRITEK GMBH, Universidad de La Frontera
- Responsible party
- Principal investigator, Jose Antonio Dominguez Benitez, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002869
- Sponsor's protocol ID
- 823854
- Acronym
- INNOVA4TB
- Status last verified
- Feb 2021
- First submitted
- 27 Jun 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the only possibility of sharing data it will be as anonymized data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation in Tuberculosis
- ClinicalTrials.gov ID
- NCT04002869
- Acronym / sponsor ID
- INNOVA4TB / 823854
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Umeå University, North-Western State Medical University named after I.I.Mechnikov, INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC, ODESA SIGNIFICANT DISEASES CENTER, Vinnitsa National Medical University, SERVICIOS CLINICOS SA, Genome Identification Diagnostics GmbH, EMPE DIAGNOSTICS AB, MAGRITEK GMBH, Universidad de La Frontera
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Active TB suspicion | – | Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnosticThis 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 |
| Latent TB infection | – | Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnosticIndividuals 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. |
| NTM infection | – | Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnosticAdult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation. |
| Uninfected control | – | Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnosticBoth adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs |
| Other respiratory diseases | – | Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnosticSubjects 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 |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Immunosuppression will not be considered an exclusion criterion
Key exclusion criteria (1 listed)
- Patients who are not able to give their informed consent to participate in the study will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunologic, molecular, metabolomic and radiolologic diagnosticEvaluation and development of new technologies | Diagnostic test | Active TB suspicion, Latent TB infection, NTM infection, Other respiratory diseases, Uninfected control |
Primary outcome
Diagnostic accuracy
Time frame: 01/01/2019 to 31/12/2022
Sensitivity, Specificity and predictive values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided. the only possibility of sharing data it will be as anonymized data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE A DOMINGUEZ BENITEZ, PhD (34 93 497 86 97 ext. 8697, jadominguez@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 01/01/2019 to 31/12/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.