Active clinical trials for "Tuberculosis, Multidrug-Resistant"

To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse-free cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among regions with high second line drug use and resistance is still limited. The investigators propose an observational study under programmatic conditions to evaluate the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan, Uzbekistan.

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice. In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis (MTB) and drug resistance has become a high priority. The Xpert® MTB/RIF Assay does not provide information on INH-resistance and the LPA is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. Several novel assays have been recently developed/CE-marked offering high sample throughput and higher sensitivity for detection of MTB, RIF- and INH-resistance in centralized laboratories. However, published data on their performance and operational characteristics is extremely limited. This is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised TB assay solutions will be assessed at the intended setting of use with culture, phenotypic DST and sequencing as reference standard. Potential trial participants will be identified at participating TB clinics or hospitals (enrolment sites). Sputum samples will be collected and transported to the associated TB reference laboratories (testing sites). In order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary TB undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden TB countries. Additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the FIND specimen bank will be used.

The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.

Background: Drug resistant tuberculosis is a serious public health problem that threatens the health of human life and the development of society and economy. At present, the diagnosis of drug-resistant tuberculosis mainly depends on traditional drug susceptibility test. But it is limited in Mycobacterium tuberculosis slow growth speed, traditional solid drug sensitivity test usually need to 3 months to results, delay the development of drug resistance in patients with effective treatment. Probe melting curves resistance detection technology is the recent emergence of a new molecular biology and drug resistant tuberculosis detection technology, probe melting curves with different fluorescent labeled probe coverage detection specific to M.tuberculosis drug resistance determining region, through changes in the melting point of the probe hybridization, acquire mutation information of detection region, shorten detection time and detect nonuniform resistance. In this study, by selecting a nationally representative in different levels of hospitals jointly launched multi center, large sample clinical assessment, completed the comprehensive evaluation of sensitivity, specificity and health economics of drug resistant pulmonary tuberculosis, especially resistance to multidrug and extensively drug-resistant TB patients detection,in order to evaluate the rapid, accurate and economic and appropriate technology of drug resistance pulmonary tuberculosis detection. In order to accomplish the overall goal of the project, in the framework of the overall design, according to the principles of the core tasks are divided into four sub topics, namely: Sub topic 1 of the core mission is included in 3100 cases of smear positive pulmonary TB suspicious symptoms, from which selected more than 1000 cases of drug-resistant pulmonary tuberculosis patients, using MGIT liquid culture and drug sensitivity test as the gold standard,evaluate the sensitivity and specificity of probe melting curves in detction of resistance of four kinds of anti tuberculosis drug to Mycobacterium tuberculosis; Sub topic 2 core task is including at least 500 cases of culture positive pulmonary tuberculosis patients and treatment follow-up, using MGIT liquid culture and drug sensitivity test as the gold standard, evaluate the application value of probe melting curves for monitoring spectrum changes of drug resistance of Mycobacterium tuberculosis during pulmonary tuberculosis treatment. The core mission of sub topic 3 is to project implementation of hospital as the research site,acquire the cost-effect evaluation and analysis by comparing probe melting technology with Mycobacterium tuberculosis MGIT liquid culture, and drug sensitivity test with xpert MTB/RIF technology.

The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air that come from the lungs of an infected person. The risk of infection will be compared between two groups: household members, who live with people having TB that does not respond well to treatment and household members, who live with people having TB that responds well to treatment. Study participants will include 4,500 TB infected people and 22,500 of their household contacts. Study procedures include answering a questionnaire, TB skin tests, blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to provide sputum samples. Individuals with TB will be involved in the study for up to 48 months; household contacts will be involved in the study for 12 months. The knowledge gained from this study will be used to improve tuberculosis control.

Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany. The aim the study is the identification of biomarkers for therapy response.