View clinical trials related to Tuberculosis.
Filter by:The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effect of increasing doses of RPT on autoinduction of RPT metabolism.
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at increased risk of TB. Those at increased risk are defined as either newly arrived immigrants or people who have been in contact with TB cases. The study will also provide information on the cost effectiveness of different testing strategies, such as the two step testing approach recommended by NICE. The study is to be funded by the NIHR Health Technology Assessment programme. 10,000 participants will be recruited from 12 hospitals and a network of GP surgeries in London. All participants will have the skin test and blood taken for both assays. Disease status of participants will then be followed up for an average of 24 months using the national register of clinical reports, a phone call and the national microbiological database. The risk of developing active disease is highest in the first two years after exposure. During followup there will be no additional diagnostic procedures unless symptoms occur, i.e. in line with current NICE policy. A sub group of patients, selected as a random 25% of participants, will have a repeat IGRA test shortly after the first test to investigate whether the skin test affects the result of the blood test.
Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, and is diagnosed in approximately 5-10% of TB patients. The incidence of TBM has increased considerably during the last decade, partly due to the HIV epidemic. Without treatment, virtually all patients with TB meningitis will die. With the current treatment regimens, TBM is fatal in approximately 30-50% of cases, and responsible for severe disability in a similar proportion of survivors. Worldwide, Indonesia the third highest case load of tuberculosis with an estimated 500,000 new patients / year. Representative data are lacking, but it is clear that TBM is a growing problem. For instance, in Hasan Sadikin Hospital, the top-referral hospital for West Java Province (population 40 million), Indonesia, 40-50 cases of TBM were treated yearly in the late 90's compared to approximately 100 in recent years. There is very little evidence for the current treatment regimen for TBM, which dates back to the late 60's. Therefore, there is an urgent need to evaluate intensified treatment of TBM in randomized trials. We hypothesize that higher dose rifampicin, moxifloxacin (possibly also at high dose), or both will improve outcome of TBM. To determine the experimental regimen(s) which should be compared with current regimen in phase 3 trials, we want to evaluate pharmacokinetic aspects and toxicity of candidate regimens in a phase 2 clinical trial in 60 patients with TBM in Indonesia.
In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) scan frequently show discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal diagnosis. The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced CT and PET scan with and without EBUS-TBNA, this study will be performed.
The immune responses in latent tuberculosis are poorly understood. While it is difficult to define the onset of latency during natural infection, patients undergoing treatment for tuberculosis are driven into a state of latency or cure. The present study on the effect of 3 and 4 month regimens containing moxifloxacin in sputum smear and culture positive pulmonary tuberculosis (TRC Study number 24) offers us the opportunity to study definitive immune responses pre and post treatment. We will evaluate a variety of innate and adaptive immune responses in patients before and after treatment and our study will compare the differences in immuno-phenotype (eg. Markers of T, B and NK cell activation, proliferation and regulatory phenotype) and function (eg. Production of cytokines, proliferative responses to TB antigens) at different time points following treatment. In addition, since a small percentage of patients will undergo relapse following treatment, the kinetics of immune responses in these patients will used to assess immunological predictors of relapse in tuberculosis.
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults. This study consists of 650 adults subjects (ages 18-50 years of age inclusive) who will receive study vaccine or placebo at Study Day 0 and again 6-9 months later. Samples for real-time evaluation of immunogenicity were to be collected from 70 subjects (immunogenicity analysis set).
To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on TB development will also be evaluated.
The aim of the trial is to assess the safety, tolerability and immunogenicity of two doses of RUTI® vaccine administered four weeks apart after one month pre-treatment with INH. The trial will be double-blinded, randomized and placebo-controlled with 96 subjects (48 HIV- and 48 HIV+ subjects). Three different RUTI® doses and placebo will be tested, randomizing assigned both in HIV+ and HIV- subjects. Each subject will be randomized to receive one of the four treatments (placebo, 5, 25, 50 μg), after completion of one month INH pre-treatment (one tablet of 300mg/day, vp.o.). Each subject will receive two administrations of the same treatment, 28 days apart. Subjects will be monitored until one month after the second inoculation with RUTI®.
Tuberculosis is a global public health problem. One third of the world's population is infected with tuberculosis (TB) with almost 2 million deaths per year globally. According to the WHO, Pakistan ranks 8th amongst the 22 high TB burden countries, with an estimated prevalence is 263 cases /100,000 populations. In spite of effective therapy for drug sensitive TB, treatment failure occurs frequently leading to concerns for the emergence of multi-drug resistant (MDR) and extensively drug resistant (XDR) mycobacterial strains. Therefore in the recent years, interest has been generated regarding the role of adjuvant immunomodulating therapy for the treatment of TB. WHO has classified tuberculosis by disease severity into 3 distinct categories; mild, moderate and severe according to clinical presentations and host factors. Severity of disease has been linked to mycobacterium genotypes and with host factors such as vitamin D deficiency Vitamin D is a hormone produced by the body in response to sun exposure. Independent of it's effects on bone mineralization, vitamin D is recognized to have numerous immune modulating effects; some specific to mycobacterium tuberculosis. Therefore vitamin D may enhance the host immune responses against the pathogen. Vitamin D status can be accurately determined by measuring the serum levels of 25-(OH) D3. A recent systemic review and meta-analysis explored the association between low serum vitamin D and risk of active tuberculosis and concluded that patients with tuberculosis have lower serum levels of vitamin D than healthy controls when matched for sex, age, ethnicity, diet and geographical location. Vitamin D deficiency is not a life threatening condition. It usually is unrecognized or can present with generalized 'aches and pains' due to osteomalacia. The recommended dose for treatment of vitamin D deficiency is 200,000 IU/ month or 50,000 IU/ week, both given for 2 months or until the serum vitamin D level is > 30 ng/ml. Bone mineral density changes are usually completed by 10 weeks of treatment. The investigators hypothesize that by replacing vitamin D in patients with active pulmonary tuberculosis, the 'Time to Recovery' can be shortened.Our aims are to determine whether replacing patients with insufficient and deficient levels of vitamin D affects the clinical outcome of the disease.