An observational study in Tuberculosis, sponsored by Irene Latorre Rueda. Not yet recruiting. Open to participants aged 5 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Irene Latorre Rueda · Observational
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:
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 940 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with Irene Latorre Rueda as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with bacteriologically confirmed pulmonary active TB diagnosed ≤14 days from the start of anti-TB treatment.
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.
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.
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.
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).
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 24 months is below that.
Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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