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Tuberculosis clinical trials

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NCT ID: NCT01390987 Completed - Tuberculosis Clinical Trials

Access to Care and Adherence Tuberculosis (TB) Survey

TBsurvey
Start date: June 2011
Phase: N/A
Study type: Observational

Prompt access to care and treatment adherence are the hearth of tuberculosis control. This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires.

NCT ID: NCT01381757 Terminated - Clinical trials for Tuberculosis, Pulmonary

Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali

Start date: May 31, 2011
Phase:
Study type: Observational

Background: -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also gives information on which drugs will work best in each case. Objective: -To test a new method for diagnosing tuberculosis called the microscopic observation drug susceptibility test. Eligibility: - Participants must be 12 years of age or older. - They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an x-ray indicating that TB is present. Design: - Participants will take part in the study from 6 months to 21 months and be assigned to one of three groups, depending on what type of TB they have. - At the first visit, researchers ask questions about general health and symptoms of TB. They check vital signs, draw blood, and ask for a sputum sample. The blood is used to check for HIV infection and for the number of CD4 cells, which measures the severity of the HIV infection. - The 2-, 5-, and 6-month visits are similar to the first. Those who do not have multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with MDR TB will remain in the study for 21 months. - No treatment is provided as part of this study.

NCT ID: NCT01380119 Completed - Tuberculosis Clinical Trials

Tuberculosis (TB) Immunotherapy Phase 2 Study

imm02
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

NCT ID: NCT01380080 Completed - HIV Infection Clinical Trials

REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

REMEMBER
Start date: October 2011
Phase: Phase 4
Study type: Interventional

People with HIV have a high chance of becoming infected with TB, especially when they live in areas where TB infection is common. It can be difficult to diagnose TB in people who need to start HIV treatment right away. Within about 6 months after starting HIV treatment, some of these people can become very sick with TB and can even die from it. This study was being done in people who were starting HIV treatment and who lived in areas where the TB infection rate is high. The purpose of this study was to test an experimental approach to TB treatment to see if it is better than the usual approach. The experimental approach was to start TB treatment at the same time as HIV treatment, even when TB infection had not been found. The usual approach was to start TB treatment only if TB infection was found. In this study, half of the people started TB treatment at the same time as they started their HIV treatment. The other half started TB treatment only if TB infection was found. The study also tested how safe and effective it was to start TB treatment at about the same time as HIV treatment even when TB infection had not been found. The study collected information about diet, whether (and when) people in the study became sicker or died, how well their HIV was controlled, how they were feeling, how they were taking their medications, whether it mattered where they lived or what kind of HIV and TB care was standard, how many people were diagnosed with TB while in the study, and how the cost of the two treatment options on a national level could be compared.

NCT ID: NCT01379066 Completed - Clinical trials for Pulmonary Tuberculosis

Tuberculosis Volatile Organic Compounds

TBVOC
Start date: August 2009
Phase: N/A
Study type: Observational

The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. It consists of: - A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air. - Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography. - Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection. - Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography. This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses: - that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification - that the investigators can identify control of tuberculosis by sampling exhaled breath

NCT ID: NCT01378312 Completed - Tuberculosis Clinical Trials

A Study to Evaluate Safety and Immunogenicity of AERAS-402

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

This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India. The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.

NCT ID: NCT01376843 Completed - Tuberculosis Clinical Trials

Conversion Rate of (TST) Tuberculin Skin Test and Quantiferon-TB Gold In Tube Assay in Health Care Workers

Start date: June 2011
Phase: N/A
Study type: Observational

The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.

NCT ID: NCT01371916 Completed - Clinical trials for Tuberculous Meningitis

Diagnosis of Tuberculous Meningitis by ESAT-6 in CSF

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

Early and reliable diagnosis of tuberculous meningitis (TBM) still poses a great challenge. One of the underlying difficulties is due to the fact that tubercle bacilli are mainly not present in the cerebrospinal fluid (CSF) but in the phagocytotic macrophages. The present study was designed to demonstrate early secretory antigenic target 6 (ESAT-6), a mycobacterium-specific antigens, in the macrophages in infected CSF samples and compare the efficiency of this antigen in the laboratory diagnosis of TBM.

NCT ID: NCT01365702 Recruiting - Tuberculosis Clinical Trials

Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

Start date: June 2011
Phase: N/A
Study type: Observational

The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.

NCT ID: NCT01364324 Completed - Tuberculosis Clinical Trials

Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Start date: September 2010
Phase:
Study type: Observational

The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).