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Tuberculosis clinical trials

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NCT ID: NCT01363765 Completed - Tuberculosis Clinical Trials

Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil

Start date: February 2012
Phase: Phase 4
Study type: Interventional

Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.

NCT ID: NCT01358162 Completed - Tuberculosis Clinical Trials

Phase IC Study of Safety and PK of SQ109 300mg Daily

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

Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics.

NCT ID: NCT01356095 Completed - Tuberculosis Clinical Trials

A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

Start date: March 2011
Phase: N/A
Study type: Interventional

Despite increased emphasis on evidence based practice in recent years a gap remains between evidence and practice, particularly in resource poor countries. Few studies to date have examined the use of knowledge translation strategies to improve health care outcomes in low income countries. However, given that the majority of health care in these settings is provided by workers with less training and limited resources, the theoretical potential for knowledge translation strategies to improve health care delivery and outcomes by integrating best evidence into routine practice may be greatest in these settings. Knowledge translation (KT) is an approach to changing health care provider behavior to reduce the gap between evidence and practice in health care delivery. There has been a tendency for knowledge translation interventions to employ generic, "off the shelf", strategies, and apply them to deal with specific issues. This generic approach, fails to recognize the variability in the specific characteristics of health care settings, in terms of their patient populations, health care systems, and health care providers. These characteristics, whether they function as barriers or facilitators to change, make a generalized approach to KT ineffective, where a tailored strategy, which specifically adjusts its approach to measured local barriers and facilitators may achieve better alignment of practice to evidence. This is likely to be particularly true in low income countries where the majority of health care is provided by non-physician health care workers, working within a wider range of health care systems, with variable and unique patient populations and resource constraints. Given the potential to significantly impact health care outcomes at relatively low cost, further research is needed both to develop methods for identifying potential barriers and facilitators to KT strategies in specific resource poor settings, and to evaluate the effectiveness of KT strategies tailored to address the identified barriers. This study will assess the effectiveness of a two part knowledge translation intervention tailored to address factors identified in a previous study as functioning as barriers and facilitators to treatment adherence among patients on treatment for tuberculosis or combined tuberculosis and antiretroviral treatment, targeting improved patient adherence and health outcomes, in a specific low income country.

NCT ID: NCT01350674 Suspended - Tuberculosis Clinical Trials

Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes

Start date: December 2010
Phase: N/A
Study type: Interventional

This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or hilar lymph nodes. The investigators analyse the specificity and sensibility of this technique to diagnose tuberculosis in mediastinal and/or hilar lymph nodes. Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and without other lymph nodes that are more easily accessible or palpable will be included in this study.

NCT ID: NCT01344148 Recruiting - AIDS Clinical Trials

Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.

Start date: February 2009
Phase: N/A
Study type: Interventional

To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8 weeks after initiation of TB treatment.

NCT ID: NCT01341184 Completed - Tuberculosis Clinical Trials

TMC207 +/- Rifabutin/Rifampin

Start date: October 21, 2011
Phase: Phase 1
Study type: Interventional

Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy volunteers

NCT ID: NCT01340820 Completed - Tuberculosis Clinical Trials

Study of AERAS 422 in Healthy Adults

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

The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.

NCT ID: NCT01331811 Completed - HIV Clinical Trials

Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)

Start date: April 2011
Phase: N/A
Study type: Interventional

Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children. The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as: - interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test - alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate - the Xpert MTB/RIF assay

NCT ID: NCT01329250 Terminated - Tuberculosis Clinical Trials

Pharmacokinetics and Safety of Moxifloxacin

MFX468
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose (600 mg; 800 mg) of moxifloxacin (MFX). This clinical trial will provide important safety information on MFX in a higher dosage in TB patients.

NCT ID: NCT01322841 Completed - Tuberculosis Clinical Trials

Universal Screening for Tuberculosis and Anemia With the CHICA System

Start date: October 2007
Phase: N/A
Study type: Interventional

The CHICA system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. The investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.