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Tuberculosis clinical trials

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NCT ID: NCT00341042 Terminated - HIV Clinical Trials

Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis Research

Start date: January 4, 2005
Phase:
Study type: Observational

This study, conducted in Bamako, Mali (West Africa), will collect blood and sputum samples to establish normal values for laboratory test results among Malians. Researchers are starting a new initiative to study HIV and tuberculosis in Africa, using Mali as a model country. In order to perform these studies, the scientists need to know what constitutes normal laboratory values among the population. People in developing countries may have dramatically different laboratory values from those who live in developed countries, and there is currently little information available to distinguish normal from abnormal results in Malians. This study will establish normal ranges that will provide a basis for future HIV and tuberculosis research in Mali. Additionally it will provide blood and sputum samples to researchers to study different scientific questions related to HIV and Tuberculosis infection. Healthy volunteers and people infected with HIV or tuberculosis, or both, who are 18 years of age or older and who live in Bamako, Mali, may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood test. Participants provide a blood or sputum sample, or both, for laboratory analysis. Blood is collected through a needle inserted into an arm vein, and sputum is collected by having the participant cough deeply and spit in a cup. Participants may agree to provide samples one time only or on a returning visit basis. Returning visits may be scheduled daily or weekly. Subjects may continue to participate for the duration of the 4-year study, provided their medical history and physical examination are updated once a year.

NCT ID: NCT00340990 Completed - Clinical trials for Mycobacterium Tuberculosis

Immune Responses to Mycobacterium Tuberculosis

Start date: October 6, 2003
Phase:
Study type: Observational

This study, conducted at the University of Mali in the capital city of Bamako, will investigate how the body reacts to infection with Mycobacterium tuberculosis (MTB), the organism that causes tuberculosis. Tuberculosis is a major global health problem whose solution requires development of an effective vaccine. However, incomplete understanding of how immunity to MTB is acquired and measured limits vaccine development. This study will focus on certain immune system cells - CD4+ T cells - that appear to be very important in fighting tuberculosis. Individuals 16 years of age and older who have or have not been exposed to either tuberculosis or HIV, or both, may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, review of medical records and laboratory tests, and, if medically indicated, a chest x-ray. Individuals whose medical records indicate a past history of tuberculosis or a positive test for exposure to tuberculosis will have a tuberculin skin test. For this test, a few drops of fluid are placed under the skin to see if the immune system reacts to the substance, indicating previous exposure to MTB. Participants will come to the University of Mali 10 times over a 1-year period - 7 times within the first 3 months of the study and then once every 3 months until 1 year after enrollment. At each study visit, they will be asked about their medical history and will donate 75 milliliters (about 1/3 cup) of blood, totaling 830 mL over the entire year. More blood may be requested if the participant's immune system reacts strongly to MTB in laboratory tests. No more than 450 mL (2 cups) of blood would be collected every 6 weeks; this amount is the Red Cross limit for regular blood donations every 6 weeks. The blood samples will be used for tests that measure the level of immunity to tuberculosis. Genetic tests may be performed on blood cells to help interpret special tests of immunity. Because HIV-infected people are included in the study, the findings may also provide information on how HIV renders vulnerability to opportunistic infections, including tuberculosis.

NCT ID: NCT00338793 Completed - Clinical trials for Tuberculous Pleurisy

Corticosteroids in the Treatment of Tuberculous Pleurisy

Start date: July 2006
Phase: N/A
Study type: Interventional

Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.

NCT ID: NCT00332306 Active, not recruiting - Tuberculosis Clinical Trials

Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment

Start date: June 2006
Phase: Phase 3
Study type: Interventional

Protocol Summary Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial Phase: Phase III trial Population: 180 HIV-1 positive patients with tuberculosis Number of Sites: Four. 1. Tuberculosis Research Centre, Chennai 2. Government Medical College, Vellore 3. Government Hospital of Thoracic Medicine, Tambaram 4. Government Rajaji Hospital, Madurai Study Duration: 26 months including 24 months of ART. Study Objectives: Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points. Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).

NCT ID: NCT00330304 Completed - Tuberculosis Clinical Trials

Isoniazid Prophylaxis With Concomitant Cotrimoxazole in HIV-infected Children

Start date: January 2003
Phase: Phase 3
Study type: Interventional

The study involves use of isoniazid and cotrimoxazole as strategies for preventing infections in HIV-infected children and reducing mortality. Cotrimoxazole is well known to reduce mortality and infections in HIV-infected children and is currently the recommended standard of care. However, isoniazid has only been studied in HIV-infected adults (in whom it has been shown to substantially reduce the incidence of tuberculosis). In a randomised controlled study of isoniazid in HIV-infected children, the investigators found that INH reduced mortality and tuberculosis incidence in excess of 50%; the data safety monitoring board recommended termination of the placebo arm given the beneficial effects of INH. The investigators therefore aim to follow-up these children to compare the long term impact of two different INH and CTX preventive regimens (daily versus thrice weekly) on morbidity, mortality, adherence and incidence of adverse reactions. The investigators also aim to investigate the efficacy, safety and tolerability of INH compared with placebo for prevention of TB in children receiving HAART as the benefit in this group is unknown.

NCT ID: NCT00317330 Completed - Tuberculosis Clinical Trials

A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of Tuberculosis

Start date: December 2004
Phase: Phase 3
Study type: Interventional

This study will test the effectiveness of two different tuberculosis (TB) prevention strategies, DOTS or DOTS-A. DOTS is the current prevention strategy for TB. DOTS-A is an enhanced prevention strategy that will screen household members of individuals diagnosed with active TB and will provide enhanced treatment as needed. The study will be conducted in 8 communities located in Rio de Janeiro. Study participants will include 6400 males and females of all ages, including active TB patients and their household contacts. Patients with TB identified for treatment at the Health Clinics of 8 urban communities will be eligible. The communities will be assigned to 1 of the 2 prevention strategies, DOTS or DOTS-A. After 4 years, the information gathered during the study will be used to determine the incidence of TB in these communities to see which prevention strategy was more effective in decreasing TB.

NCT ID: NCT00313066 Recruiting - Tuberculosis Clinical Trials

Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion

Start date: November 2005
Phase: Phase 4
Study type: Observational

Connective tissue growth factor (CTGF) is known to be a fibrogenic cytokine, it could be expressed in various fibrosis diseases. But, recent research showed that CTGF also be considered to be a tumor suppressive gene. The expression of CTGF protein is higher in normal Type I and II alveolar epithelial cells than metastatic tumor cells. CTGF appears to be a suppressor of lung tumor invasion and in metastasis and the decreased CTGF expression in tumor tissues was associated with advanced tumor stage, lymph node metastasis, early postoperative relapse and shorter patient survival. CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, peritoneal mesothelial cells and lung but did not known in the pleura. The CTGF protein is present in the peritoneal cavity and is increased during peritonitis. Considering pleural cavity comes from the same origin of mesenchyma with peritoneum, pericardium and fallopian tube, we aim to evaluate whether the CTGF expression increase in the pleurisy patients including the parapneumonic effusion and the TB pleurisy. The diagnosis of TB pleurisy depends on the effusion TB culture and pleural biopsy. Unfortunately the sensitivity of TB culture was only 20-30%. So most patients must receive invasive pleural biopsy. Adenosine deaminase(ADA) was developed as a screening test but should not be considered an alternative test to culture and biopsy. The sensitivity of ADA might vary from 32%-100% and the cutoff value also vary from 26 to 70 IU/L. We should develop a method to alternate the culture and biopsy . Therefore, our technologist Jao-Jia chu will develop the CTGF ELISA kit for this specific aim. If CGTF might increase expression in pleuritis but decrease in pleural metastasis, it might be a potential method help to differentiate lymphocytic pleural effusion between TB pleurisy and malignancy.

NCT ID: NCT00311298 Completed - Diabetes Clinical Trials

Nutrition, Diabetes and Pulmonary TB/HIV

Start date: April 2006
Phase: Phase 3
Study type: Interventional

We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries. The overall objective of the proposed trial is to assess the effect of nutritional support on TB treatment outcomes, and to assess the role of diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of 500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-, irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily energy-protein bar containing either low or high MN content.

NCT ID: NCT00311220 Recruiting - Tuberculosis Clinical Trials

Use TST and QFT-RD1 Test to Monitor the Tuberculous Infection in Patients, Close Contact People and Health Care Workers

Start date: January 2004
Phase: Phase 4
Study type: Interventional

Tuberculosis is still the most common infectious disease in Taiwan. The infants in Taiwan have been vaccinated at birth with BCG -Tokyo 171 strain since 1951. The BCG vaccination rate is 97% among first grade students in a recent national survey. Even with such a high BCG vaccination coverage, Taiwan still has a relatively high TB incidence rate. In 2004, there were totally 16,784 newly diagnosed TB cases and the annual incidence was 74.11 per 100,000 population nationally. Nearly 70% of the incidence cases were men and 30.4% were women. The mean age of incidence cases was 57.8 years old (median=63). 8,440(50.29%) patients were elderly than 65 years old. The elderly men did not receive the BCG vaccination and were the most important group to develop newly diagnosed tuberculosis and a special issue for the national TB control program in Taiwan. The tuberculin skin test (TST) is the only widely available method for detecting whether people have an immunologic reactivity to mycobacterial antigens and identified as latent tuberculosis infection (LTBI). Targeted tuberculin testing for latent TB infection is a very important strategy to identify subjects with high risk to develop tuberculosis including those who have recent infection with Mycobacterium tuberculosis or have clinical conditions that associated with an increased risk for progression of LTBI to active TB but the sensitivity was lower in elderly patients. Quantiferon-TB gold test (QFT-RD1) is a new diagnostic test for latent tuberculosis and a valuable alternative to skin testing. This whole-blood assay measures the production of IFN-  in whole blood upon stimulation by ESAT-6 and CFP-10 and allows distinction of latent M. tuberculosis infection from BCG-induced reactivity. ESAT-6 and CFP-10 are deleted from BCG Region 1 (RD1), not present in most nontuberculous mycobacteria and are highly specific indicators of M. tuberculosis infection. Thus, the aim of this study was to estimate the specificity and sensitivity of a whole blood IFN-γassay employing CFP-10 and ESAT-6, for the detection of M. tuberculosis infection in a clustered high risk elderly population. Changhwa Veterans Home is a government-expense veterans home with totally 519 residents in 2004.The inhabitants were all elderly people and lived in groups. , They did not receive BCG vaccination and were the high risk group to develop endemic TB infection. The annual TB incidence rate over there was 3,500 per 100,000 population.

NCT ID: NCT00311207 Recruiting - Lung Cancer Clinical Trials

Development of Tuberculosis Diagnostic Kit

Start date: December 2005
Phase: Phase 3
Study type: Observational

Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality. Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.