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Tuberculosis clinical trials

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NCT ID: NCT01124929 Completed - Tuberculosis Clinical Trials

Treatment Duration for Abdominal Tuberculosis

RNTCP-DOTS
Start date: July 2008
Phase: Phase 3
Study type: Interventional

Most of the guidelines on the treatment of tuberculosis suggest that 6 months treatment is sufficient for extrapulmonary tuberculosis except for bone tuberculosis and tubercular meningitis. Despite these recommendations, most physicians treating abdominal tuberculosis use antituberculous therapy for 9 months, sometimes even 12 months without any scientific justification. In a randomized controlled trial, Balasubramaniam et al reported no difference in success rate of 6mo (99%) vs 12 months (94%) antituberculous drugs (conventional strategy) in the treatment of abdominal tuberculosis. Although Directly Observed Therapy (DOTs) have been proved to be effective in patients with pulmonary tuberculosis, lymph nodal tuberculosis, however, there is a lack of data on efficacy of DOTS in other extra-pulmonary disease including abdominal tuberculosis. Therefore, there is an urgent need to establish the efficacy of DOTs strategy of antituberculous therapy in the treatment of abdominal tuberculosis. Therefore, the investigators planned to conduct a multicenter randomized controlled trial to determine the difference in the recurrence of disease after only observation for three months and three months extension of DOTs in a subset of patients with definite clinical response after 6 months of DOTs.

NCT ID: NCT01121068 Completed - Tuberculosis Clinical Trials

Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients

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

Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis. However,IGRA responses could show within-subject variability. We wanted to determine long-term IGRA variability in health-care workers who continuously expose to tuberculosis patients.

NCT ID: NCT01119521 Completed - Tuberculosis Clinical Trials

Study of Pre-clearance of Latent Tuberculosis Infection And BCG Revaccination

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

The purpose of this research is to further study the tuberculosis (TB) vaccine, Bacillus Calmette Guérin (BCG). The goal of this study is to evaluate whether the BCG vaccine is more effective in preventing TB in adults if it is given after 6 months of treatment with a widely used anti-TB drug, isoniazid (INH). Participants will include 82 healthy, tuberculin skin test positive (TST+), HIV-uninfected, male and female volunteers, aged 18-40 years. The study will be conducted in Worcester, South Africa. Subjects will be assigned by chance to 1 of 2 possible treatment groups. Group 1 will receive 6 months of oral INH treatment followed by intradermal (administered into the skin) BCG revaccination and one year of follow-up. Group 2 will be observed for 7 months which will be followed by intradermal BCG revaccination and another 6 months of follow-up. Then 6 months of INH treatment will be given. Participants will be involved in study procedures for about to 22 months.

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: 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.