Opti-4TB: A protocol for a prospective cohort study evaluating the performance of new biomarkers for active tuberculosis outcome prediction.
Olivier Bahuaud, Charlotte Genestet, Jonathan Hoffmann...
https://pubmed.ncbi.nlm.nih.gov/36186786Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04271397
Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers
Led by Hospices Civils de Lyon · Updated on 2024-08-12
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tuberculosis (TB) is a leading cause of death worldwide from infectious disease, with active TB requiring a lengthy and complex antibiotic treatment that can cause significant side effects and challenges in adherence, particularly in primary care. This research aims to evaluate four new immunological biomarkers to improve the diagnosis accuracy and outcome prediction for active TB and latent tuberculosis infection. The study is sponsored by Hospices Civils de Lyon and focuses on optimizing TB diagnosis and management using these biomarkers.
CONDITIONS
Brief Title
Immunological Biomarkers in Tuberculosis Management
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients who have provided written consent
- Patients willing to be followed for at least 6 months
- Patients with confirmed active tuberculosis by positive direct examination or PCR
- Patients with latent tuberculosis infection confirmed by positive IGRA
You will not qualify if you...
- Presence of malignant solid tumor
- Presence of malignant hemopathy
- History of solid organ or hematopoietic stem cell transplantation
- Use of immunosuppressive treatments such as biologics, calcineurin inhibitors, or corticosteroids
- Auto-inflammatory diseases
- Chronic liver diseases
- Chronic infection with HIV, hepatitis C virus, or hepatitis B virus
- Antimycobacterial treatment started more than 7 days prior
- Pregnancy or breastfeeding
- Refusal to participate in the study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection
- Patients not affiliated with health-care social security
- Homeless individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - 6 months
Participants provide blood samples for biomarker testing to assist in diagnosis and management of tuberculosis.
5 blood sample visits over 6 months for active tuberculosis; 1 blood sample visit for latent tuberculosis infection
Trial Site Locations
Total: 1 location
1
Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, France, 69004
Actively Recruiting
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Research Team
F
Florence ADER, M.D., Ph.D
O
Oana DUMITRESCU, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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