Equivalence Study of Specificity of PPD
Tuberculosis InfectionDetermine if investigational products and reference standard produce similar responses.
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
TuberculosisThis study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
Anti-tuberculosis (TB) Drug Levels and Correlation With Drug Induced Hepatotoxicity
HepatitisTuberculosisThe purpose of the study is to estimate plasma drug levels ( free and total drug levels ) of rifampicin and other antituberculosis drugs and compare these drug levels in patients who develop drug induced hepatotoxicity versus those who do not .The study hypothesis is that the ATT drug induced hepatotoxicity is related to free drug levels of rifampicin and other antituberculosis drugs .
Screening for Tuberculosis in HIV-infected Patients Eligible for Antiretroviral Treatment
HIV InfectionTuberculosisBackground: Increased access to antiretroviral therapy (ART) in Africa will require decentralization to primary health care. For this purpose, adapted methods for management of patients co-infected with tuberculosis (TB) and HIV are needed. Improved detection of TB in patients starting ART, and assessment of co-administration of ART and TB treatment are priorities in this field. Aims: To identify clinical predictors of TB in patients starting ART, and to construct screening algorithms for TB in this population; to assess ART outcomes in patients receiving TB treatment at health centre level. Work plan: The project is performed in health centres providing ART in Ethiopia. A cohort of HIV positive patients initiating ART is prospectively followed. Baseline characteristics are registered; blood samples for CD4 cells, HIV RNA and immunological markers are collected, as well as sputum for TB culture and PCR. During ART, clinical data, CD4 cell counts and HIV RNA levels are followed. Patients with TB are compared to those without TB with regard to ART outcome. Baseline factors associated with TB will be used to construct TB screening algorithms. Recruitment of the cohort was completed in March 2013; follow-up for determination of long term outcome of ART will be continued until 2016. Significance: These studies give insight into TB-HIV co-infection at primary health care level in a Sub-Saharan region, and may impact future guidelines for management of such patients.
An Open Cohort of Childhood Tuberculosis in Mbarara National Referral Hospital, Uganda
TuberculosisThe aims at investigating how the diagnosis of Tuberculosis in children in a setting of high TB and HIV prevalence can be improved and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
The Role of Tuberculosis in Chronic Obstructive Lung Disease
The Role of Tuberculosis in COPDInfluence of tuberculosis (TB) on natural course of chronic obstructive lung disease (COPD) has not been well known. This study was designed to investigate the effects of history of TB on the long-term course of COPD.
Diagnostic Trial to Validate the Use of the E-Nose in Pulmonary TB
TuberculosisPulmonary1 moreDetermine the diagnostic accuracy for pulmonary tuberculosis in adults of the E-Nose in Venezuela.
Improving the Management of Drug Resistant Tuberculosis in the UK
TuberculosisThe 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. In the UK, for example, 6.8% of the ~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible. Currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. Data from randomised controlled trials, the peak quality of evidence, is sparse. It is thus important that studies using pre-existing observational data are undertaken. The investigators aim to use data and samples collected from Public Health England and National Health Service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and will have been notified to Public Health England. The study will be conducted at University College London, National Health Service hospitals and Public Health England and will last until December 2017. Patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.
Efficacy of Nyaditum Resae(R) Against Active TB in Georgia
Close Contacts of Active TuberculosisThe use of a supplement food like "Nyaditum resae" is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance. In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.
Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
Pulmonary TuberculosisTitle: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the developing world. Despite the introduction of the highly sensitive and specific GeneXpert MTB/RIF (GeneXpert) test [1] with a potential turn-around time of two hours, many people in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical constraints in these settings. A cost effective, rapid, point-of-care screening test with high sensitivity would identify people with a high likelihood for active TB and would prioritize them for testing with more expensive, technically or logistically demanding assays including GeneXpert or liquid culture, facilitating cost-effective diagnostic work-up in resource-limited settings. A serum cytokine signature for active TB disease, discovered in the AE-TBC project, with a sensitivity of 89% (CI 78 - 95%) and specificity of 76% (CI 68 - 83%), will be optimised and utilized in a point-of-care format (TransDot) to rapidly test for TB disease in symptomatic people. Hypothesis: The TransDot test will achieve a sensitivity of > 90% for TB disease, in a training set of people suspected of having TB disease, and be validated (achieve similarly high sensitivity) subsequently in a prospective test set of people suspected of having TB disease, when compared to a composite gold standard of sputum culture, smear, GeneXpert, chest X-ray, TB symptoms and TB treatment response. Objectives: The overall objective of the study is to incorporate a six-marker serum signature into a multiplex UCP-LFA format, referred to as TransDot, for finger-prick blood testing. The end point of the study is the accuracy (sensitivity and specificity) of the UCP-LFA TransDot test on finger-prick blood for active TB and will be prospectively compared against gold standard composite diagnostic criteria (GeneXpert, MGIT culture, TB sputum smear, CXR, TB symptom screen and response to TB treatment). Primary: The primary outcome of interest will be accuracy, sensitivity and specificity of the TransDot finger-prick test when compared with the composite gold standard tests.