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Tuberculosis clinical trials

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NCT ID: NCT01113281 Completed - Tuberculosis Clinical Trials

Dose-Escalation Study on Safety and Immunogenicity of VPM1002 in Comparison to BCG in Healthy Volunteers in South Africa

Start date: April 2010
Phase: Phase 1
Study type: Interventional

Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. The new vaccine should be at least as potent as the current strain and should be safer than BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised bacteria to be re-suspended before intradermal injection. The preceding clinical trial in 80 volunteers in Germany indicated immunogenicity and safety being sufficient for proceeding with the clinical development. Hence, the current study is commenced in South Africa, a country highly endemic for tuberculosis. 24 volunteers were randomly allocated to 4 groups each with 6 adult healthy volunteers.

NCT ID: NCT01099098 Completed - Tuberculosis Clinical Trials

Prevalence of Latent Tuberculosis (TB) Infection Diagnosed by Interferon-gamma Release Assay and Tuberculin Skin Tests in Patients With Old Healed TB

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

We easily regard nodules and fibrosis in upper lobes of lung as TB sequelae. The aim of this study is to confirm the prevalence of latent TB infection diagnosed by interferon-gamma release assay and tuberculin skin tests in patients with old healed TB.

NCT ID: NCT01098474 Completed - Tuberculosis Clinical Trials

Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

Start date: July 7, 2010
Phase: Phase 2
Study type: Interventional

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.

NCT ID: NCT01071603 Completed - Tuberculosis Clinical Trials

Tuberculosis in China

Start date: February 2, 2010
Phase:
Study type: Observational

Background: - In spite of well-researched treatments and therapies, 5 to 10 percent of tuberculosis (TB) patients who have initially successful TB treatments will relapse, usually within a year after completion of therapy. This percentage is even greater for patients who are infected with multi-drug resistant and extensively drug resistant types of TB. Because the People s Republic of China has the second highest number of TB cases in the world, researchers are interested in studying TB patients in China to evaluate their response to treatment on a long-term basis. Objectives: - To improve TB diagnosis and testing by determining the number and proportion of patients admitted with suspected TB who actually have TB (definite or probable). - To assess the prevalence of non-tuberculosis bacteria among patients with presumed TB. Eligibility: - Individuals between 18 and 65 years of age who have been admitted to Henan Provincial Chest Hospital with suspected tuberculosis. Design: - Participants will be divided into three groups, based on their diagnosis after admission. Another group of individuals who do not have TB will be enrolled as controls for comparison purposes during the study. - The study will use computed tomography (CT) scans of the chest at initial enrollment, 2 months, and 6 months to evaluate disease response to treatment. Incidents of TB that are not in the chest area (extrapulmonary TB) will also be studied. - The study will also monitor the treatments and therapies used against the disease, changes in patients immune systems, and any changes in the biological samples taken over the course of treatment.

NCT ID: NCT01061593 Completed - HIV Clinical Trials

Adjunct Immunotherapy With Immunoxel in Patients With TB and TB/HIV

Start date: January 2010
Phase: Phase 3
Study type: Interventional

Dzherelo (Immunoxel) is an oral immunomodulating botanical agent available over-the-counter in Ukraine. After many years of laboratory and clinical testing the formulation was approved in 1997 by the Ministry of Health of Ukraine as a dietary herbal supplement, which enhances immunity against viral and infectious diseases. The goal of this study is to conduct confirmatory clinical trial in Ukraine and Mongolia for TB indications.

NCT ID: NCT01059422 Recruiting - HIV Infections Clinical Trials

Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The study will investigate whether combination antiretroviral therapy of raltegravir and 3TC/ABC is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-containing, first-line antituberculous treatment. Hypothesis:Combination antiretroviral therapy of raltegravir and 3TC/ABC and is effective and safe to use in tuberculosis (TB)/HIV co-infected adults receiving rifabutin-based first-line antituberculous treatment.

NCT ID: NCT01053598 Completed - HIV Infections Clinical Trials

Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting

NRA RETA
Start date: September 2011
Phase: N/A
Study type: Observational

The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard. The Secondary objectives are: - To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients - To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients - To assess the time to detection of both NRA/NRA-p, REMA-p methods. - To evaluate the feasibility of the NRA, NRA-p, REMA-p methods. - To determine the rate of contamination of the NRA, NRA-p and REMA-p assays. - To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting. - To provide capacity building for TB diagnosis in Mbarara.

NCT ID: NCT01049282 Completed - Tuberculosis Clinical Trials

A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

THYB-03
Start date: December 2008
Phase: Phase 1
Study type: Interventional

The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

NCT ID: NCT01048697 Completed - Obesity Clinical Trials

Effect of Weight and/or Obesity on Ethambutol Drug Concentrations

Start date: January 2010
Phase: Phase 4
Study type: Interventional

This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who are leaner.

NCT ID: NCT01043575 Completed - Clinical trials for Smear Positive, Pan-sensitive, Pulmonary Tuberculosis

High Dose Rifapentine Pharmacokinetics, Tolerability and Safety Dosage Rifapentine for Treatment of Tuberculosis

TBTC-29PK
Start date: April 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.