View clinical trials related to Tuberculosis.
Filter by:The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Across Europe and worldwide, there are many studies following groups (cohorts) of children living with human immunodeficiency virus (HIV) and other infections over time, to monitor their long-term health. Some of these infections are rare: for example, few children in Western Europe are living with HIV, so the studies often have fairly small numbers of participants. This can make it difficult to answer research questions in these cohorts and means that doctors and researchers working with these patients in different countries need to work together. This is particularly important as children are not often included in clinical trials of treatments and other interventions. The European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) is an international network of researchers working together in this way. Researchers in the network represent cohort studies of pregnant women and children with, or at risk of, infections from across Europe and Thailand. The research focuses on infections in pregnant women and children, particularly HIV, hepatitis B and C virus, and tuberculosis, and, from 2020, novel coronavirus (COVID-19). By combining data from many cohorts, the researchers aim to answer questions that could not be answered by one study individually (for example, because a large number of pregnant women or children are needed to answer the question). This protocol focuses on the paediatric component of EPPICC's research, which focuses on the treatment of children at risk of and living with infections. For example, what medicines are used most often and how do they affect children's health? EPPICC is an observational study, which means that children do not receive any extra treatment as part of the study. Instead, children are "observed" during their routine medical care. Each cohort keeps records of the children's health collected at routine clinic visits, including information such as date of birth and sex, results of diagnostic tests, treatments received, and any illnesses or other events that the children have had. The EPPICC study combines and analyses data from all of the cohorts that take part, to answer questions about the risks and benefits of different diagnosis or treatment strategies, the long-term effects of infection and treatment during childhood and young adulthood, and regional variations (e.g. between Western and Eastern Europe) in the risk and management of infections. All of the data collected through the EPPICC Paediatric Protocol are stored securely at the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. Data collection and storage are governed by the General Data Protection Regulation. A Steering Committee guides the research to make sure it is relevant and of high quality. Public and patient involvement (PPI) may be provided by individual cohorts' own groups, as well as by the interlinked Penta organisation, which is a network of paediatricians and researchers working in infections in Europe and globally. The PPI groups help with release of the results of the research. The results are also published on the Penta Foundation's public website (https://penta-id.org/), and presented at conferences and published in Open Access scientific journals.
The new drug pyrifazimine (previous name: TBI-166) developed by the Institute of Materia Medica of the Chinese Academy of Medical Sciences which is Beijing Union Pharmaceutical Second Factory relied on is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects. In addition, pyrifazimine has a weak effect on liver drug enzymes, and is suitable for combined use in the clinical treatment of tuberculosis. The development of the drug is expected to provide a new method for the clinical treatment of drug-resistant tuberculosis, benefit patients, and produce good social benefits. In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets (formerly chemical drug registration classification 1.1) obtained the drug clinical approval issued by the CFDA (batch number: 2016L10025/2016L09987), and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation. In accordance with relevant requirements of drug registration regulations, technical guidelines, etc., this project has completed the safety, tolerability, and pharmacokinetic clinical trials of a single dose of pyrifazimine tablets in healthy subjects, i.e. Phase Ia clinical trials test.
A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.
The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.
HIV-infected people have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among people living with HIV (PLHIV), the World Health Organization (WHO) recommends systematic TB screening followed by 1) confirmatory TB testing for all those who screen positive and 2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative. The objective of the TB Screening Improves Preventive Therapy Uptake (TB SCRIPT) trial is to determine whether TB screening based on C-reactive protein (CRP) levels, measured using a rapid and low-cost point-of-care (POC) assay, improves TPT uptake and clinical outcomes of PLHIV, relative to symptom-based TB screening.
About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI). Risk factors like malnutrition, diabetes mellitus (DM), and helminth infection can affect the development of active TB. Researchers want to study LTBI individuals with these issues to see how they may contribute to a person s higher risk for developing active TB. This study will take place in Chennai, India. Objective: To estimate the prevalence of malnutrition, DM, and helminth infections in people with LTBI. Eligibility: People age 14 65 with or without LTBI. Design: Participants will be screened with a medical history and physical exam focused on symptoms of active TB. Those who have TB symptoms will not take part in the study. Those who do not have TB symptoms will have a physical exam with vital signs, height, and weight. They will give blood and stool samples. Participants will be assigned to 1 of 6 groups. They will repeat some of the screening tests. They will give urine samples. Some groups will have a chest X-ray. Some groups will have an ultrasound of the abdomen. Participants will complete a survey about their history of smoking and drug and alcohol use. Participants will have data collected about their nutritional status and body composition. Their skinfold thickness, ratio of waist/hip circumference, and grip strength will be measured. Participants with DM, malnutrition, or helminth infection will be given standard of care or referred for follow-up treatment. Participation will last up to 6 months. ...
The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations
Currently in Taiwan, most clinicians use sputum smear and culture for the diagnosis of pulmonary tuberculosis (TB) and apply nucleic acid amplification (NAA) test in a selected manner. In 2013, the World Health Organization issued conditional recommendation that Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults suspected of having TB. The newly published Taiwan guidelines for TB diagnosis and treatment has recommended NAA test, together with smear and culture, as the initial diagnostic test in individuals suspected of having TB. The investigators conduct a prospective study to investigate the use of Xpert MTB/RIF as the initial diagnostic test of pulmonary TB under a pragmatic trial design.