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Tuberculosis clinical trials

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NCT ID: NCT02875574 Completed - Tuberculosis Clinical Trials

Improving the Management of Drug Resistant Tuberculosis in the UK

UK_DR-TB
Start date: November 2016
Phase: N/A
Study type: Observational

The '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.

NCT ID: NCT02874755 Completed - Tuberculosis Clinical Trials

Quality of Tuberculosis Care in Mumbai, India

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in the private health sector of Mumbai city, India.

NCT ID: NCT02874716 Completed - Tuberculosis Clinical Trials

Quality of Tuberculosis Care in Urban Patna, India

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of health care. The PPIA is a tuberculosis pilot program implemented in the private health sector of urban Patna in the state of Bihar, India.

NCT ID: NCT02861768 Completed - Tuberculosis Clinical Trials

Improving the Diagnostic of Tuberculosis

Start date: March 22, 2013
Phase: N/A
Study type: Interventional

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis. Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal. Secondary 1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely. 2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely. 3. Beijing genotype prevalence among patients with pulmonary tuberculosis.

NCT ID: NCT02845570 Recruiting - Tuberculosis Clinical Trials

Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB

Start date: July 2016
Phase: Phase 1
Study type: Interventional

Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this PET tracer, including identification of subclinical disease in latently infected individuals. This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis.

NCT ID: NCT02840877 Completed - Tuberculosis Clinical Trials

The Impact of Alcohol Consumption on Tuberculosis Treatment Outcomes

Start date: May 16, 2017
Phase: N/A
Study type: Interventional

After HIV/AIDS, tuberculosis (TB) remains the second leading cause of death due to an infectious disease globally. Retrospective studies from many countries, including the United States and South Africa, have consistently reported that in addition to having a higher burden of TB disease, patients with problem alcohol use have worse TB treatment outcomes. This prospective study will attempt to clarify both behavioral and biologic causal mechanisms underlying the deleterious effects of problem alcohol use on TB treatment response.

NCT ID: NCT02836483 Completed - Clinical trials for Pulmonary Tuberculosis

A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

Start date: December 10, 2016
Phase: Phase 2
Study type: Interventional

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

NCT ID: NCT02822014 Completed - Clinical trials for Extrapulmonary Tuberculosis in HIV Patients

PET/CT in Extrapulmonary TB in HIV Patients: a Clinical Trial

Start date: February 2010
Phase: N/A
Study type: Interventional

Objective Prospectively describe the kinetics of 18F-FDG uptake of extrapulmonary TB after two months and at the end of TB treatment in HIV patients. Evaluate 18F-FDG-PET/CT as a TB treatment response monitoring tool. Design The investigators performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients. The investigators correlated evolution of FDG uptake with clinical evolution of patients.

NCT ID: NCT02821832 Completed - Clinical trials for Pulmonary Tuberculosis

Using Biomarkers to Predict TB Treatment Duration

Start date: June 21, 2017
Phase: Phase 2
Study type: Interventional

Background: Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long. Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might show who will be cured after only 4 months of treatment. Objective: To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people with less severe TB. Eligibility: People 18-75 years old who have TB treatable with standard TB drugs Design: Participants will be screened with: Medical history Physical exam Blood and urine tests HIV test Sputum sample: Participants will be asked to cough sputum into a cup. Chest x-ray Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6 more times during the 18-month study. Visits include: Sputum samples Physical exam Blood tests PET/CT scans at 2-3 visits: Participants fast for about 6 hours before the scan. Participants get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein. They lie on a table in a machine that takes pictures of the body. Chest x-rays at 1-2 visits Participants who we believe are likely to be cured at 4 months will be randomly assigned to get either 6 months of treatment or 4 months of treatment. Participants may be asked to join a substudy using their sputum samples or additional blood tests.

NCT ID: NCT02816931 Completed - Clinical trials for Tuberculosis, Multidrug Resistant

Drug Concentrations in the Treatment of MDR-TB Related to Minimum Inhibitory Concentrations

TDM-MDR-TB
Start date: March 2016
Phase:
Study type: Observational

Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the need of improved treatment strategies. In order to protect the few available drugs that are left, ensuring adequate plasma concentrations of the drugs are important. Individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance (1). The plasma drug concentrations and the MICs of the second-line drugs will be compared, aiming at increasing the knowledge about pharmacokinetic/pharmacodynamic (PK/PD) indices in the treatment of MDR-TB. In the future, the aim is an individualised therapy, where sub-therapeutic drug concentrations can be adjusted by the use of therapeutic drug monitoring (TDM). TDM in the treatment of MDR-TB may improve clinical outcome for the patients, but plasma concentrations must be assessed together with clinical and microbiological factors (2). In this observational study the hypothesis is that the ratio between drug concentrations and MICs of the anti-tuberculous drugs, are correlated to the time to sputum culture conversion, the bacterial load measured as time to positive liquid culture (TTP) and clinical outcome. Consenting adult patients with pulmonary MDR-TB patients in China will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 8 weeks after treatment initiation using liquid chromatography tandem mass spectrometry (LC-MS/MS), simultaneously assessing Dried Blood Spot (DBS) as a bio-sampling method. Sputum cultures will be obtained regularly throughout the treatment to measure the time to culture positivity (TTP). Clinical follow up according to WHO criteria will be performed at the end of treatment completion.