Health Trials

Questioning the Epidemiology of Asymptomatic TB

ConditionsTuberculosisTuberculosis (TB)HIVHIV (Human Immunodeficiency Virus)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBarcelona Institute for Global Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

Documented HIV infection

Presenting at a health facility for routine HIV care

Disqualifiers

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

Trial population

Participants attending routine HIV care at the Manhica District Hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

6,770 Participants
are grouped into 2 trial groups
Group A: Asymptomatic
Group B: Symptomatic

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

Symptomatology of asymptomatic TB

The objectively measured frequency of symptoms among asymptomatic TB cases compared to that of symptomatic TB cases

Time frame
2 weeks
2

Clinical trajectory of aTB

The proportion of aTB cases with measurable signs of progression to symptomatic or worsening TB disease compared to those who self-clear.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barcelona Institute for Global Health

Lead sponsor

Source ClinicalTrials.gov
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