Prospective Assessment of TBDx Feasibility
Pulmonary TuberculosisThe purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.
Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis...
Pulmonary TuberculosisThe goal of this single-center, open-labelled, clinical trial in two groups aims to proof that a specific group of antibiotics (carbapenems) can be used to treat pulmonary tuberculosis if it is combined with another antibiotic (amoxicillin/clavulanate). A total of 113 male or female participants (8 groups and 9 treatment regimens as group 8 was split into 2 groups of 4 participants receiving Rifafour e-275), aged between 18 and 65 years (inclusive), with newly diagnosed, smear-positive, pulmonary TB.
Early Retinal Nerve Fiber Layer Change of Ethambutol Optic Neuropathy by Optical Coherence Tomography...
Primary Lung TuberculosisEthambutol is widely used as first-line drug, but has serious side effect of optic neuropathy. As previously reported, incidence of ethambutol optic neuropathy is about 1~2%, there was considerable screening efforts and medical cost is increasing. However, there is no effective treatment of ethambutol optic neuropathy or no definite preventable measure. Moreover, multi-drug resistance tuberculosis or extensively drug resistance tuberculosis is emerging, more toxic secondary drug is used in the long-term. It is known that retinal nerve fiber layer is increased early stage in ethambutol optic neuropathy. So we decide to evaluate the retinal nerve fiber layer thickness measured by optical coherence tomography in longitudinal manner.
Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa
TuberculosisTuberculosis3 moreThe purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults. A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
TuberculosisTuberculosis2 moreThe purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).
Diagnosing Tuberculosis in HIV Infected Children in Peru
TuberculosisTuberculosis2 moreTuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis...
Pulmonary TuberculosisTuberculosis Diagnosis2 moreIn the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software Afinion CRP assay (Alere Afinion, USA), which detects a cytokine induced acute phase protein CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis (TB). These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value. Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined, the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests. This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal, South Africa. A sub-study (detailed in a separate study protocol), hereafter called AHD-FEASIBILITY, explores the feasibility of implementing a series of point-of-care tests, including the new VISITECT CD4 Advanced Disease Test (Omega Diagnostics, UK) as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIV/TB campaigns. Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19, it is critical to test for SARS-Cov-2 infections in the study population. In addition, this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test (from the diagnostic pipeline of FIND) and CAD4COVID, a digital chest x-ray analysis software (Delft Imaging System, NL) in combination with differential white blood cell count.
Effect of Smoking Cessation on Tuberculosis Treatment Outcomes
TuberculosisPulmonaryThis study was a Randomized Controlled Trial conducted at Ojha Institute of Chest Diseases, Dow University of Health Sciences, Karachi, among pulmonary tuberculosis patients
Feasibility of a Lateral Flow Urine Lipoarabinomannan (LAM) Test for Diagnosis of Tuberculosis
TuberculosisTuberculosis3 moreThe purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults. A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.
Intensive Smoking-cessation Intervention Versus Smoking-cessation Advice in Smear-positive Patients...
TuberculosisThe aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes. Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients