TuberculosisTB-SPECTRUMNCT07735754
A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management
An observational study of Tuberculosis, run by Irene Latorre Rueda.
Trial summary
Tuberculosis (TB) is a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health. TB-SPECTRUM project will conduct a clinical study to characterize better clinically, microbiologically, and immunologically the spectrum of TB across the different stages… Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 940 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The participants will be recruited in 4 different hospitals located in Moldova (Chiril Draganiuc Institute, IPCD), Romania (Marius Nasta Institute, IPMN), Nigeria (Bingham University, BHU) and Spain (Serveis Clínics, SSCC).
Who may be able to join
- Age between 5 and 65 years
- Willing and able to provide informed consent (or legal guardian consent) *GROUP 1: Active pulmonary TB*
- Bacteriologically confirmed TB
- Pulmonary TB
- Anti-TB treatment ≤ 14 days *GROUP 2: Close contacts of active pulmonary TB*
- Close contact with confirmed pulmonary TB case
Show all 15Show fewer
- Exposure ≥6 hours/day for ≥5 days/week
- Positive TST and/or IGRA
- NOT receiving TB preventive therapy *GROUP 3: Other respiratory diseases (non-TB)*
- Diagnosis of ARI (Acute Respiratory Infection) and/or sarcoidosis and/or lung cancer
- Clinical/radiological findings consistent with non-TB disease
- NO clinical suspicion compatible with active TB *GROUP 4: Healthy uninfected controls*
- No symptoms suggestive of active TB
- Not known prior exposure to active TB
- Negative TST and/or IGRA
Who cannot join
- Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)
- Known or suspected pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Tuberculosis (TB) is a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health. TB-SPECTRUM project will conduct a clinical study to characterize better clinically, microbiologically, and immunologically the spectrum of TB across the different stages of infection, including incipient and asymptomatic/subclinical TB, active disease, and post treatment phases. Passive and active case-finding (ACF) clinical approaches will be implemented, recruiting TB patients through public and private healthcare facilities and targeted community outreach, as well as their close contacts. This approach will allow the study of biomarker profiles associated with infection risk, disease progression and response to treatment. The specific objectives of the study will be:
- To unravel immune mechanisms underlying the TB spectrum through a multidisciplinary approach.
- To perform a clinical study (passive and ACF) for recruiting patients and their contacts for the enrolment of incipient/subclinical TB forms and the subsequent immune characterization and management.
- To characterize host systemic and local immune responses on different TB immune states (with special focus on incipient, subclinical and cured TB) to better understand host-pathogen interactions and the established cellular/humoral immune mechanisms.
- To stratify host immunity according to patient's clinical strain characterization and disease severity.
- To develop and evaluate innovative tools for better management of all phases of the TB spectrum.
- Conditions
- Tuberculosis
- Keywords
- Pulmonary tuberculosis, tuberculosis spectrum, close contacts, Active Case Finding, host-pathogen interactions, asymptomatic tuberculosis, incipient tuberculosis
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Active TB cases | Patients with bacteriologically confirmed pulmonary active TB diagnosed ≤14 days from the start of anti-TB treatment. | |
| Group 2: Close contacts of active TB cases | Close contacts are defined as individuals sharing living spaces or spending at least 6 hours per day with index cases for at least more than 5 days per week. Both adult and pediatric cases with a positive immune test for TB infection (TST and/or IGRA) will be included, although IGRA will be performed at every visit if available. Only those contacts not currently receiving TB preventive treatment will be enrolled and monitored at the different timepoints. | |
| Group 3: Controls with other respiratory diseases | Individuals with non-TB respiratory condition. Specifically, subjects with Acute Respiratory Infection (ARI), sarcoidosis or lung cancer; without any clinical picture compatible with the criteria defined in TB cases section. | |
| Group 4: Healthy uninfected controls | Volunteers asymptomatic for active TB and for whom active disease has been excluded based on clinical examination and appropriate medical investigations, with no known prior exposure to a confirmed pulmonary TB case, and no immunological evidence of M. tuberculosis infection, proved with negative TST and/or IGRA result. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.
Measured: Close contacts (group 2) recruited in clinical sites (IPMN, IPCD, BHU and SSCC) and followed at baseline, 3 months and 12 months with clinical assessments and samplings. And symptoms will be monitored remotely by phone up to 24 months after enrollment.
Characterization of treatment monitoring and cured TB across the TB-SPECTRUM assesed by clinical, immunological, microbiological and molecular assays.
Measured: Clinical assesments and sampling will be done in active TB cases (Group 1) at month 2, 6, and post-treatment (2-6 months after treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (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
- 940 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Irene Latorre Rueda
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Bingham University, University of Texas, Instituto de Investigação e Inovação em Saúde (i3S), Genome Identification Diagnostics GmbH, "Marius Nasta" Pulmonology Institute, INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC, SERVICIOS CLINICOS SA
- Responsible party
- Sponsor-investigator, Irene Latorre Rueda, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735754
- Sponsor's protocol ID
- 101236673
- Acronym
- TB-SPECTRUM
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Step Forward for Unraveling the Immune Mechanisms and Tools for Tuberculosis Spectrum Management
- ClinicalTrials.gov ID
- NCT07735754
- Acronym / sponsor ID
- TB-SPECTRUM / 101236673
- Conditions
- Tuberculosis
- Keywords
- Pulmonary tuberculosis, tuberculosis spectrum, close contacts, Active Case Finding, host-pathogen interactions, asymptomatic tuberculosis, incipient tuberculosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 940 participants (estimated)
- Lead sponsor
- Irene Latorre RuedaUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Bingham University, University of Texas, Instituto de Investigação e Inovação em Saúde (i3S), Genome Identification Diagnostics GmbH, "Marius Nasta" Pulmonology Institute, INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC, SERVICIOS CLINICOS SA
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Jul 2026 (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 a significant infectious disease worldwide, with millions of people infected and major impact on mortality and public health. TB-SPECTRUM project will conduct a clinical study to characterize better clinically, microbiologically, and immunologically the spectrum of TB across the different stages of infection, including incipient and asymptomatic/subclinical TB, active disease, and post treatment phases. Passive and active case-finding (ACF) clinical approaches will be implemented, recruiting TB patients through public and private healthcare facilities and targeted community outreach, as well as their close contacts. This approach will allow the study of biomarker profiles associated with infection risk, disease progression and response to treatment. The specific objectives of the study will be:
- To unravel immune mechanisms underlying the TB spectrum through a multidisciplinary approach.
- To perform a clinical study (passive and ACF) for recruiting patients and their contacts for the enrolment of incipient/subclinical TB forms and the subsequent immune characterization and management.
- To characterize host systemic and local immune responses on different TB immune states (with special focus on incipient, subclinical and cured TB) to better understand host-pathogen interactions and the established cellular/humoral immune mechanisms.
- To stratify host immunity according to patient's clinical strain characterization and disease severity.
- To develop and evaluate innovative tools for better management of all phases of the TB spectrum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Active TB cases | – | –Patients with bacteriologically confirmed pulmonary active TB diagnosed ≤14 days from the start of anti-TB treatment. |
| Group 2: Close contacts of active TB cases | – | –Close contacts are defined as individuals sharing living spaces or spending at least 6 hours per day with index cases for at least more than 5 days per week. Both adult and pediatric cases with a positive immune test for TB infection (TST and/or IGRA) will be included, although IGRA will be performed at every visit if available. Only those contacts not currently receiving TB preventive treatment will be enrolled and monitored at the different timepoints. |
| Group 3: Controls with other respiratory diseases | – | –Individuals with non-TB respiratory condition. Specifically, subjects with Acute Respiratory Infection (ARI), sarcoidosis or lung cancer; without any clinical picture compatible with the criteria defined in TB cases section. |
| Group 4: Healthy uninfected controls | – | –Volunteers asymptomatic for active TB and for whom active disease has been excluded based on clinical examination and appropriate medical investigations, with no known prior exposure to a confirmed pulmonary TB case, and no immunological evidence of M. tuberculosis infection, proved with negative TST and/or IGRA result. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants will be recruited in 4 different hospitals located in Moldova (Chiril Draganiuc Institute, IPCD), Romania (Marius Nasta Institute, IPMN), Nigeria (Bingham University, BHU) and Spain (Serveis Clínics, SSCC).
Key inclusion criteria (15 listed)
- Age between 5 and 65 years
- Willing and able to provide informed consent (or legal guardian consent) *GROUP 1: Active pulmonary TB*
- Bacteriologically confirmed TB
- Pulmonary TB
- Anti-TB treatment ≤ 14 days *GROUP 2: Close contacts of active pulmonary TB*
Key exclusion criteria (2 listed)
- Known or suspected immunodeficiency (including HIV or immunosuppressive therapy)
- Known or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays.
Time frame: Close contacts (group 2) recruited in clinical sites (IPMN, IPCD, BHU and SSCC) and followed at baseline, 3 months and 12 months with clinical assessments and samplings. And symptoms will be monitored remotely by phone up to 24 months after enrollment.
Characterization of treatment monitoring and cured TB across the TB-SPECTRUM assesed by clinical, immunological, microbiological and molecular assays.
Time frame: Clinical assesments and sampling will be done in active TB cases (Group 1) at month 2, 6, and post-treatment (2-6 months after treatment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Irene Latorre Rueda.
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 15 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Dominguez, PhD (+34 935 54 30 50 ext. 6500, jadominguez@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the different TB-SPECTRUM stages (focusing on incipient and asymptomatic TB) assessed by clinical, immunological, microbiological and molecular assays. (time frame: Close contacts (group 2) recruited in clinical sites (IPMN, IPCD, BHU and SSCC) and followed at baseline, 3 months and 12 months with clinical assessments and samplings. And symptoms will be monitored remotely by phone up to 24 months after enrollment.). The study lists 2 primary outcomes in all. 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 30 Jul 2026.