Questioning the Epidemiology of Asymptomatic TB

NCT07312266 | Recruiting DMC

• 2 other identifiers: 101117940ERC-2023-STG-101117940
• Study Type: observational
• Target: 6,770
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) remains one of the world's leading causes of morbidity and mortality. Current TB control strategies focus largely on the binary paradigm of TB, which tackle Mtb infection and the symptomatic stages of the disease as the major drivers of the TB epidemic. However, prevalence surveys have shown that about 50% of cases in which Mycobacterium tuberculosis is isolated from sputum but do not report having symptoms. Therefore, asymptomatic TB may play an important role in TB transmission. However, no field study has demonstrated direct transmission from a subclinical TB case to a confirmed secondary case. TB-QUEST is an ERC-funded epidemiological field study that aims to provide direct evidence of effective transmission from asymptomatic TB cases to their close contacts using advanced genomic methods, and to better characterize the asymptomatic stage of TB within the natural history of disease.

Conditions

Tuberculosis; Tuberculosis (TB); HIV; HIV (Human Immunodeficiency Virus)

Keywords

Asymptomatic tuberculosis; Asymptomatic; Subclinical tuberculosis; Subclinical

Outcome Measures

Primary Outcomes (1)

• Proportion of secondary cases arising from TB index case transmission

  Transmission from aTB cases will be compared to that of clinical cases by: i) comparing the proportion of genomically-linked secondary cases and ii) by comparing the proportion of QFT conversion and host transcriptomic changes

  12 months

Secondary Outcomes (2)

• Symptomatology of asymptomatic TB

  2 weeks

• Clinical trajectory of aTB

  12 months

Study Arms (2)

Asymptomatic

Contacts of bacteriologically-confirmed asymptomatic TB index cases

Symptomatic

Contacts of bacteriologically-confirmed symptomatic TB index cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants attending routine HIV care at the Manhica District Hospital

You may qualify if:

• years of age or older
• Documented HIV infection
• Presenting at a health facility for routine HIV care

You may not qualify if:

• History of TB treatment in the last 12 months
• Pregnant women
• Refusal to provide consent for study procedures
• Contra-indication to any sampling procedure required by the study
• On ART for less than 6 months
• No evidence of viral suppression
• Documented CD4 count \>350 copies/ul
• TB-suggestive x-ray
• Verified absence of fever and cough, as ascertained through the symptom trackers
• Contacts:
• Plans to migrate in the next 12 months
• Pregnant women
• Currently taking anti-tuberculosis treatment or preventive TB treatment
• Contacts with co-prevalent TB identified at baseline

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead

Study Sites (1)

Centro de Investigação em Saúde de Manhiça (CISM)

Manhiça, Maputo Province, Mozambique

RECRUITING

Related Links

• Project webpage

Biospecimen

Retention: SAMPLES WITH DNA

Sputum, tongue swabs, urine, stool, blood, saliva

MeSH Terms

Conditions

Tuberculosis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Alberto L. Garcia-Basteiro, MD

CONTACT

+34 93 227 1806; alberto.garcia-basteiro@isglobal.org

Joanna Ehrlich

CONTACT

+34 93 227 1806; joanna.ehrlich@isglobal.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

MO (1)