The Role of a Mycobacterium Growth Inhibition Assay to Quantify Host Immune Control of M. Tuberculosis
MGIA
1 other identifier
observational
280
1 country
2
Brief Summary
The goal of this observational study is to learn about how the blood leucocytes from patients with and without exposure or disease from tuberculosis (TB) are able to kill live mycobacteria (M. tuberculosis). The main question it aims to answer is: Is intracellular growth suppression of M. tuberculosis in peripheral blood mononuclear cells variable among healthy blood donors and higher than in patients with latent TB compared to active TB?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedAugust 30, 2024
August 1, 2024
4.6 years
August 28, 2024
August 28, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Mycobacterial inhibition of host macrophages
Mycobacterial inhibition of host macrophages
Up to 10 days incubation
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
Mycobacterial inhibition of host peripheral blood mononuclear cells (PBMCs)
Up to 10 days incubation
Secondary Outcomes (1)
Cytokine expression of host peripheral blood mononuclear cells (PBMCs)
24 hours
Study Arms (4)
Healthy Individuals
Patients with a negative IGRA (Quantiferon) who are apparently healthy.
Close contacts to patients with active TB
Close contacts to patients with active, smear positive pulmonary TB.
Patients with (latent) tuberculosis infection
Patients without active TB who have a positive IGRA (Quantiferon Plus) result.
Patients with active TB
Culture or PCR-verified active TB who are initiated on treatment.
Interventions
Blood sampling for analysis of mycobacterial growth inhibition assay (MGIA) analysis.
Eligibility Criteria
Subjects who are attending the infectious disease clinics at region Östergötland och region Kalmar, Sweden.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kalmar County Hospital
Kalmar, 391 85, Sweden
Dept of Infectious Diseases
Linköping, 581 85, Sweden
Biospecimen
PBMCs are collected and frozen in liquid nitrogen. Whole blood is stored separately for DNA and epigenetic analyses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Schoen, Professor
Linkoeping University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 28, 2024
First Posted
August 30, 2024
Study Start
August 1, 2020
Primary Completion
March 1, 2025
Study Completion
December 1, 2025
Last Updated
August 30, 2024
Record last verified: 2024-08