Active clinical trials for "Tuberculosis"

On a global scale, tuberculosis (TB) is the single most important infectious cause of morbidity and mortality. The World Health Organization has estimated that one-third of the entire world's population carries latent TB infection. A key TB control strategy is therapy of latent TB infection (LTBI). The current standard regimen is 9 months of Isoniazid (9INH). This regimen has excellent efficacy if taken regularly, but its effectiveness is substantially reduced by poor compliance. Serious side effects, such as hepato-toxicity can occur. Three shorter alternatives have been recommended: 6 months INH (6INH), 2 months Rifampin - Pyrazinamide (2RIF-PZA) and 4 months Rifampin (4RIF). The regimen of 6INH is less efficacious than 9INH, while 2RIF-PZA has been largely abandoned because of serious toxicity. Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the investigators are initiating the first multi-site international randomized trial that will compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis.

Purpose of the study is to evaluate the safety and efficacy of different re-introduction regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such patients who developed drug induced liver damage.

This study, conducted in Masan and Seoul, South Korea, investigated the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular medicines do not work well against XDR TB, many more people die from it than from regular TB, which can be successfully treated by taking TB medication for 6 months. Linezolid has been used to treat other kinds of infections, but has not been well studied for TB. This study examined the side effects and effectiveness of prolonged treatment with linezolid at two different doses. People 20 years of age and older who have XDR TB were eligible for this 3-year study. Participants underwent the following tests and procedures: LZD treatment: Patients were randomly assigned to one of two study groups. Group 1 patients were observed for 2 months before starting LZD, while group 2 patients begin taking LZD right away. Both groups began with a 600 mg daily dose of LZD. After patients stopped coughing up TB germs (or after 4 months on LZD) they were randomly assigned either to continue taking 600 mg of LZD for the rest of the study or to take a decreased dose of 300 mg. In addition to LZD, patients continued to take their currently prescribed TB medications. Medical history. Physical examinations each month during treatment. Sputum collections once a week or more until 3 weeks after the patient was no longer contagious. Blood draws every week for 16 to 24 weeks and then once a month. Urine collections at several time points. Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects. CT scans of the lungs three to four times the first year and once more later in the study. For this test the patient lay on a table within the doughnut-shaped CT scanner while special X-ray pictures are taken. Patients who participated in a substudy had PET scans instead of the CT scans. For this test, the patient was given an injection into a vein of a radioactive chemical that can be detected by a special camera and viewed on a screen. The patient lay on a table within the doughnut-shaped scanner while pictures were taken.

The aim of this study is to evaluate the safety of a new vaccine against Tuberculosis (RUTI) when administered to healthy adult volunteers, compared to placebo; and determine its safe dosage range. An initial evaluation of immune responses to the vaccine compared to placebo will also be undertaken. In the present Phase I clinical trial, four increasing doses of RUTI will be tested, the groups composed by 6 volunteers each. (Total of 24 volunteers). The escalation to a new dose to test will be done after the safety of the previous dose has been ensured. For each dose of FCMtb to test, each volunteer will be inoculated twice (at day 0 and day 28) with RUTI (4 volunteers) or placebo (2 volunteers) and will be followed-up up to 25 weeks from the first inoculation. The global length of the study will be approximately 15 months.

The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken.

Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.

The Temprano trial is based on the following assumptions: ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term. Tuberculosis and tuberculosis-related deaths are likely to represent a considerable proportion of morbidity and mortality among HIV-infected patients with high CD4 counts in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT) and early ART could enhance each others efficacy.

The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of MDR pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. The study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of MDR-TB without significantly increasing the toxicity.

In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. Data suggest that aggressive management of HIV infection, which includes Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and mortality. On the other hand, the use of HAART for patients with TB may cause severe complications due to drug-drug interactions, and occasionally a temporary exacerbation of symptoms. These reactions may be particularly severe when HAART is started soon after the start of TB treatment. The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts.

Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.