Clinical Trials Logo

Clinical Trial Summary

Current diagnostic tools such as interferon gamma release assay (IGRA) and purified protein derivative (PPD) can not distinguish patients with latent tuberculosis infection (LTBI) and persistence of live mycobacteria. This inability to rule out living mycobacteria in patients investigated for LTBI leads to unnecessary and potentially harmful treatment regimes all around the globe. The goal of this observational study is to identify candidate biomarkers for viable bacilli in latent tuberculosis in order to decrease the use of unnecessary and ineffective antibiotic treatment.


Clinical Trial Description

Tuberculosis (TB) is the second leading cause of death due to a single infectious agent, with the main burden in resource-limited settings and in vulnerable populations. It is estimated that approximately 25% of the global population is infected with TB. LTBI is a condition where the mycobacteria rests within the body instead of creating active disease. About half of the active TB cases develop within 2 years of exposure and the other half reactivates as distant as several decades post exposure. Persistence of viable bacilli is a prerequisite for the reactivation of TB. Through sampling of peripheral blood the investigators will investigate how selected cytokines, enzyme activity and gene expression changes during course of treatment, 4-6 months, and during follow up, 1 year. These patterns will be compared to the patterns of patients with: latent TB without treatment, active TB with treatment as well as healthy controls. Samples will be drawn at 0, 1, 6 and 12 months, after treatment initialization when applicable. Healthy controls will only be sampled once. Most of the analysis will be performed on TB-antigen stimulated blood. The investigators hypothesize that there is a substantial fraction of latent TB patients who do not harbor live mycobacteria and that this is reflected in study outcome measures when given treatment. Furthermore, the investigators hypothesize that this fraction of latent TB patients will resemble healthy controls in terms of outcome measures whereas their counterpart, latent TB patients harboring living bacteria, will not. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05621343
Study type Observational [Patient Registry]
Source Region Skane
Contact Petter Holmberg, PhD student
Phone +4640333108
Email petter.holmberg@med.lu.se
Status Recruiting
Phase
Start date December 21, 2021
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05073926 - Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
Not yet recruiting NCT04428294 - Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation Phase 4
Completed NCT02276755 - Vitamin D Supplementation in TB Prevention Phase 3
Withdrawn NCT03498534 - Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis Phase 4
Active, not recruiting NCT03988933 - 2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB. Phase 2
Recruiting NCT06022146 - TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts Phase 3
Active, not recruiting NCT04188041 - Improving Rhode Island's Tuberculosis Preventive Services in Primary Care N/A
Recruiting NCT03730181 - Tuberculosis Clinical Trials Consortium Study 35 Phase 1/Phase 2
Completed NCT01967134 - Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis Phase 1
Completed NCT00257907 - Immune Response to Mycobacterium Tuberculosis Infection
Recruiting NCT05756582 - Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
Active, not recruiting NCT04557176 - TB Screening Improves Preventive Therapy Uptake N/A
Completed NCT02119130 - Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa N/A
Not yet recruiting NCT06281834 - Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention Phase 1
Not yet recruiting NCT02512484 - Improving the Detection of Active Tuberculosis in Accident and Emergency Departments N/A
Completed NCT00763295 - Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV? N/A
Completed NCT01850043 - The Epidemiology of TST Change in Korea N/A
Completed NCT02073669 - Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults N/A
Completed NCT02090374 - Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen N/A
Completed NCT02880982 - Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren Phase 3