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Tuberculosis clinical trials

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NCT ID: NCT02512939 Completed - Tuberculosis Clinical Trials

Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection

NextGen
Start date: July 2015
Phase: N/A
Study type: Interventional

This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.

NCT ID: NCT02508376 Completed - Tuberculosis Clinical Trials

Safety, Tolerability, and Immunogenicity of the Vaccine Candidates ID93 + AP10-602 and ID93 + GLA-SE Administered Intramuscularly in Healthy Adult Subjects

Start date: October 22, 2015
Phase: Phase 1
Study type: Interventional

This is a phase I randomized, double blind clinical trial designed to evaluate the safety, tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will receive a total of 3 doses administered intramuscularly on Days 1, 29 and 57. Subjects will be monitored for approximately 422 days (365 days following the third study injection), including safety laboratory analyses done just prior to and 7 days following each study injection. Blood samples will be obtained for immunological assays (Luminex, intracellular cytokine staining at Days 1 and 71, and antibody analysis at Days 1 and 85). The primary objective is to evaluate the safety and tolerability of 10 µg ID93 + 5 or 10 µg AP10-602 compared to 10 µg ID93 + 5 µg GLA-SE and 10 µg ID93 alone following three consecutive intramuscular injections administered on Days 1, 29 and 57.

NCT ID: NCT02503839 Completed - Tuberculosis Clinical Trials

Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic

TBCOX2
Start date: November 2015
Phase: Phase 1
Study type: Interventional

Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue. Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the immune system and strengthen vaccines responses. Hypothesis 1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i. 2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine and enhanced by COX-2i will improve immune-mediated host clearance of TB. 3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB. Approach to test the hypothesis 1. Study design: 4-arm, open and randomized clinical intervention trial of patients starting treatment for active TB in specialized Norwegian TB centres and where two arms will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only and the last arm serve as control receiving only standard anti-TB therapy. For safety precautions, only patients bearing sensitive TB strains are included and study arms will be sequentially introduced. 2. In a mouse model examine in more detail the effects of reversion of chronic inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses, immune regulation, correlates of protection and survival in a well-characterized model for TB-exposed mice.

NCT ID: NCT02501421 Completed - Tuberculosis Clinical Trials

Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in BCG-vaccinated healthy adult subjects aged 18-50 years.

NCT ID: NCT02500277 Completed - Tuberculosis Clinical Trials

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

COFFEE
Start date: January 2015
Phase: N/A
Study type: Interventional

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

NCT ID: NCT02481726 Completed - Lung Cancer Clinical Trials

68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.

NCT ID: NCT02467608 Completed - Clinical trials for Pulmonary Tuberculosis

Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis

Start date: December 6, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis

NCT ID: NCT02465216 Completed - Clinical trials for Pulmonary Tuberculosis

Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion

Start date: June 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b prevention of TB recurrence trial in the same population.

NCT ID: NCT02457208 Completed - Tuberculosis Clinical Trials

PK Study of Anti-TB Drugs

Start date: July 7, 2015
Phase: Phase 1
Study type: Interventional

This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border. This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per WHO guidelines.

NCT ID: NCT02454738 Completed - Latent Tuberculosis Clinical Trials

Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts

Start date: June 2015
Phase: N/A
Study type: Interventional

To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.