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Latent Tuberculosis clinical trials

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NCT ID: NCT02073240 Completed - Tuberculosis Clinical Trials

Evaluation of an Enhanced Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand

EnTIC
Start date: February 17, 2014
Phase:
Study type: Observational

Study Design: Stratified, matched, cluster-randomized, controlled trial Unit of Randomization: Healthcare facility Study Duration: 3 years; prevalence of latent Tuberculosis infection (LTBI) in healthcare workers (HCWs) will be at measured at baseline, and LTBI incidence will be measured among susceptible HCWs at 12 and 24 months. Secondary outcomes will be measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In year three, results will be analyzed and disseminated. Study Components: Assessment of institutional safety culture; observations/audits of Tuberculosis (TB) patient flow (wait times) and HCW TB infection control (IC) practices; documentation of time intervals for processing sputum smears and initiation of TB treatment; facility assessments; random allocation and implementation of enhanced Tuberculosis infection control (TB IC) package; testing of HCWs to determine LTBI at 0, 12, 24 months; cost evaluation of intervention. Sample Size: For the cluster randomized design, we estimate that 11 clusters per group will allow for 77 percent (%) power to identify a 30% reduction in LTBI incidence in the intervention vs. control clusters. This assumes LTBI incidence 5% per year in the control group, design effect for clustering of 2.0, and cluster size of 300 (average 600 HCW per cluster with 50% LTBI prevalence at baseline).

NCT ID: NCT01967134 Completed - Latent Tuberculosis Clinical Trials

Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.

NCT ID: NCT01875952 Active, not recruiting - Clinical trials for Human Immunodeficiency Virus (HIV)

Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL)

HIV/TB
Start date: May 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response

NCT ID: NCT01865487 Completed - Latent Tuberculosis Clinical Trials

A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.

NCT ID: NCT01850043 Completed - Tuberculosis Clinical Trials

The Epidemiology of TST Change in Korea

Start date: May 2005
Phase: N/A
Study type: Observational

TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.

NCT ID: NCT01761201 Terminated - Clinical trials for Latent Tuberculosis Infection

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".

FLISH-ILT
Start date: January 2012
Phase: Phase 3
Study type: Interventional

A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation. Patients over 18 years of age on the waiting list for liver transplantation. Sample size: n=870 patients. HYPOTHESIS Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

NCT ID: NCT01685905 Recruiting - Clinical trials for Rheumatoid Arthritis

The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection

Start date: April 2012
Phase: N/A
Study type: Observational

The purposes of this study 1. to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G), and determine the level of agreement between two tests in patients with rheumatic diseases 2. to evaluate the difference in the occurrence of active TB in patients who receive both QFT-G and TST compared with those who receive only TST for detecting of Latent tuberculosis infection(LTBI) who are candidates of TNF inhibitors.

NCT ID: NCT01685086 Recruiting - Clinical trials for To Monitor the Occurrence of Active Tuberculosis

Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis

Start date: March 2012
Phase: N/A
Study type: Observational

To follow-up the latent tuberculosis infection and evaluate the risk of developing active tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis

NCT ID: NCT01622140 Completed - Tuberculosis Clinical Trials

Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis

Start date: October 2012
Phase:
Study type: Observational

This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.

NCT ID: NCT01608685 Completed - Clinical trials for Latent Tuberculosis Infection

Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients

Start date: January 2010
Phase: N/A
Study type: Observational

Interferon gamma release assays (IGRA) have been shown to be more specific and sensitive for the detection of tuberculosis (latent or active infection) than the tuberculin skin test (TST) in immunocompetent individuals. However, very little data are available concerning the relative performance of IGRA and TST in immunosuppressed individuals from other causes than HIV. The investigators hypothesize that IGRAs would be more sensitive and specific than the TST in a group of renal transplant recipients under chronic immunosuppressive treatment for detecting latent tuberculosis infection.