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Tuberculosis clinical trials

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NCT ID: NCT02520973 Completed - Tuberculosis Clinical Trials

Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

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

Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .

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: NCT02512484 Not yet recruiting - Latent Tuberculosis Clinical Trials

Improving the Detection of Active Tuberculosis in Accident and Emergency Departments

ACE
Start date: May 2016
Phase: N/A
Study type: Observational

Tuberculosis (TB) control remains a public health challenge. Many people in the UK do not have a general practitioner (GP) registration and their only interaction with the NHS is via Accident and Emergency (A&E) Departments of hospitals. This is often the case for those in hard to reach groups, who are also those often at highest risk of TB. This study seeks to assess whether A&E Departments are effective sites for the identification and onward management of TB, both in its latent and active forms.

NCT ID: NCT02508610 Recruiting - HIV Clinical Trials

DNA Sequencing of MDR TB in Eastern Siberia

Start date: November 2013
Phase: N/A
Study type: Observational

This is protocol is generated in response to the exploratory R21 from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID) for US-Russia collaborative research in HIV/tuberculosis (TB). Given the exploratory focus of the protocol and the short time frame of funding (2 years) we will study TB in Irkutsk, in Eastern Siberia. Irkutsk is one of the hardest-hit areas in all of the Russian Federation for drug-resistant TB and poor TB outcomes. Specifically, the investigators will examine the factors of anti-TB drug pharmacokinetics, TB drug-resistance mutations and virulent/transmissible M. tuberculosis sublineages. This foundational work will inform future diagnostic strategies and therapeutic regimens.

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: NCT02497079 Recruiting - Tuberculosis Clinical Trials

Diagnostic Accuracy of Polymerase Chain Reaction for Mycobacterium Tuberculosis Using EBUS-TBNA Samples

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

The purpose of this study is to compare the diagnostic efficacy of nested and realtime polymerase chain reaction for Mycobacterium tuberculosis using EBUS-TBNA samples in patients with isolated intrathoracic lymphadenopathy.

NCT ID: NCT02496572 Active, not recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan

Start date: September 2013
Phase: Phase 3
Study type: Observational

Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse-free cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among regions with high second line drug use and resistance is still limited. The investigators propose an observational study under programmatic conditions to evaluate the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan, Uzbekistan.