Clinical Trials Logo

Tuberculosis clinical trials

View clinical trials related to Tuberculosis.

Filter by:

NCT ID: NCT02153528 Completed - Clinical trials for Tuberculosis, Pulmonary

Optimization of the TB Treatment Regimen Cascade

OneRIF
Start date: November 2014
Phase: Phase 3
Study type: Interventional

- Hypothesis: Double dose rifampicin together with earlier monitoring of sputum conversion using vital staining reduces unfavorable outcome of Cat. 1 first-line TB treatment without excess serious toxicity, and allows early switch to specific treatment of MDR-TB without using Cat. 2 retreatment regimen - General study design: This open label, randomised clinical trial is intended as a pilot study on the efficacy and safety of high-dose rifampicin and feasibility and added value of auramine and/or FDA vital staining sputum smear after 2 weeks of intensive treatment phase. If this proof-of-concept study provides substantial indication of benefit without indication of excess toxicity, the data from the study will be used to design a larger scale, cluster-randomized study. The aim of this cluster randomised study would be to provide definite proof of the benefit of the intervention on adverse treatment outcomes and lack of excess toxicity associated with high dose rifampicin. In addition, the cluster-randomized study would provide a more precise assessment of the suppression and prevention of (acquired) resistance endpoints. An interim analysis is thus planned at the time the last recruited patient finishes treatment, i.e. about 9 months after the end of recruitment. It will focus on assessment of drug toxicity versus suggested benefits of the intervention. This analysis will be primarily performed for the go/no-go decision and design considerations for the cluster-randomized trial. The decision on proceeding to the cluster randomized study will be based on the absence of excess toxicity, a trend toward a reduction of unfavourable outcomes (excluding relapse), and possible favourable effects on initially present low-resistance mutations / mutations acquired during treatment. It will also allow to adapt the design of the larger study particularly regarding the algorithm for resistance screening, and whether or not treatment shortening could be justified with rapid initial conversion.

NCT ID: NCT02142894 Completed - Tuberculosis Clinical Trials

Evaluation of the QuantiFERON-TB Test.

Start date: May 27, 2014
Phase:
Study type: Observational

To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

NCT ID: NCT02135289 Completed - Ulcerative Colitis Clinical Trials

The Role of IGRA in Screening and Monitoring for TB During Anti TNF Therapy in Patients With IMID

IGRA
Start date: March 2012
Phase:
Study type: Observational

Hong Kong is a region of intermediate TB burden, and the reactivation of latent TB in IMID patients treated with anti-TNF can be a serious problem. This study aims to investigate the role of IGRA in screening for latent TB in IBD patients and control subjects. In part II of the study, patients of other immune-mediated inflammatory diseases (IMID) will also be included to investigate the role of serial interferon-gamma release assays (IGRA) for the diagnosis of tuberculosis (TB) infection in patients with immune-mediated inflammatory diseases (IMID) treated with biologics

NCT ID: NCT02128308 Completed - Healthy Clinical Trials

Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.

NCT ID: NCT02127983 Completed - HIV Clinical Trials

Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)

Triage
Start date: January 2009
Phase: N/A
Study type: Interventional

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

NCT ID: NCT02121314 Completed - Tuberculosis Clinical Trials

HRZE Fasted/Fed in Newly Diagnosed TB

FASTFOOD
Start date: July 2013
Phase: Phase 2
Study type: Interventional

WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food. Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage of lower drug blood concentrations over time? How exactly do the drug concentrations over time (pharmacokinetics) compare between fasting and fed conditions, especially in the early stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB drugs?

NCT ID: NCT02120638 Recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide

Start date: April 2014
Phase: Phase 3
Study type: Interventional

Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge to TB control program. That pyrazinamide can shorten the course of treatment and facilitate bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing has not been widely used in clinic. And the conventional testing is time-consuming and unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can provide rapid results of pyrazinamide susceptibility. The purpose of this study is to evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility in optimizing the MDR-TB treatment regimen.

NCT ID: NCT02119130 Completed - HIV Clinical Trials

Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa

Start date: November 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to use a cluster randomized trial to compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly faster timeframe. The cost-effectiveness of linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will be evaluated using a mixed method approach to identify steps that can be modified for future scale-up of the intervention.

NCT ID: NCT02115854 Completed - Tuberculosis Clinical Trials

Labial Biopsy in Patients With Tuberculosis Disease

Start date: December 2010
Phase: N/A
Study type: Observational [Patient Registry]

The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician. The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.

NCT ID: NCT02114684 Completed - Clinical trials for Recurrent Tuberculosis

Improving Retreatment Success (IMPRESS)

IMPRESS
Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB. The primary objective is to determine if a moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the duration of TB treatment.