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Tuberculosis, Multidrug-Resistant clinical trials

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NCT ID: NCT03057756 Active, not recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

Start date: September 11, 2015
Study type: Observational [Patient Registry]

The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.

NCT ID: NCT02503839 Active, not recruiting - Tuberculosis Clinical Trials

Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic

Start date: November 2015
Phase: Phase 1
Study type: Interventional

Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue. Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the immune system and strengthen vaccines responses. Hypothesis 1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i. 2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine and enhanced by COX-2i will improve immune-mediated host clearance of TB. 3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB. Approach to test the hypothesis 1. Study design: 4-arm, open and randomized clinical intervention trial of patients starting treatment for active TB in specialized Norwegian TB centres and where two arms will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only and the last arm serve as control receiving only standard anti-TB therapy. For safety precautions, only patients bearing sensitive TB strains are included and study arms will be sequentially introduced. 2. In a mouse model examine in more detail the effects of reversion of chronic inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses, immune regulation, correlates of protection and survival in a well-characterized model for TB-exposed mice.

NCT ID: NCT02496572 Active, not recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan

Start date: September 2013
Phase: Phase 3
Study type: Observational

Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high toxicity. Scale up of MDR TB treatment is associated with high default rates, and experience in the Medecins Sans Frontieres (MSF) programme in Uzbekistan shows that the current standard treatment greatly limits the ability to scale up to meet the high rates of MDR TB in the region. Evidence from Bangladesh in 2010 showed that a 9-month short-course regimen could achieve a relapse-free cure rate of 88%. Several countries in West Africa started implementing similar regimens with similar outcomes. Evidence of effectiveness of this shortened regimen among regions with high second line drug use and resistance is still limited. The investigators propose an observational study under programmatic conditions to evaluate the effectiveness of a shortened course MDR TB regimen in the high MDR/extensively drug resistant (XDR) TB prevalence and high second-line drug resistance setting of Karakalpakstan, Uzbekistan.

NCT ID: NCT02333799 Active, not recruiting - Clinical trials for Pulmonary Tuberculosis

A Phase 3 Study Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis

Start date: March 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for subjects who remain culture positive at month 4) in Subjects with either pulmonary extensively drug resistant tuberculosis (XDR-TB), treatment intolerant or non-responsive multi-drug resistant tuberculosis (MDR-TB).

NCT ID: NCT02274389 Active, not recruiting - Clinical trials for Pulmonary Multi-drug Resistant Tuberculosis

A Prospective Patient Registry of Patients Exposed to Bedaquiline

Start date: December 24, 2013
Study type: Observational

The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum inhibitory concentrations (MICs) reported for baseline and subsequent isolates, BDQ drug utilization data to include dose, duration, past treatment history, past medical history, concomitant medications, and health care site of treatment, drug distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and microbiologic) and adverse events among BDQ-treated participants, including deaths.

NCT ID: NCT02234908 Active, not recruiting - Tuberculosis Clinical Trials

Rewards for Tuberculosis Contact Screening

Start date: October 2014
Phase: N/A
Study type: Interventional

This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize.The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection—the patients and their families.

NCT ID: NCT01918397 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it. Drugs of the fluoroquinolone class are very important for treating MDR-TB, but the best dose of one of the most effective fluoroquinolones, levofloxacin, is not known. This application proposes a study to determine the best dose of levofloxacin to use in treating MDR-TB. 120 patients will receive their usual treatment, plus levofloxacin at one of four doses. The study will be performed in Peru and in South Africa, where MDR-TB is common.

NCT ID: NCT01859923 Active, not recruiting - Pediatric Clinical Trials

A 6-Month Safety, Efficacy, and PK Trial of Delamanid in Pediatric Patients With Multidrug Resistant Tuberculosis

Start date: July 20, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen of other anti-tuberculosis drugs in pediatric patients who completed Trial 242-12-232.

NCT ID: NCT00676754 Active, not recruiting - Clinical trials for TB Multi-drug Resistant

Epidemiology of MDR-TB in Peru

Estudio Epi
Start date: September 2009
Phase: Phase 4
Study type: Observational

The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air that come from the lungs of an infected person. The risk of infection will be compared between two groups: household members, who live with people having TB that does not respond well to treatment and household members, who live with people having TB that responds well to treatment. Study participants will include 4,500 TB infected people and 22,500 of their household contacts. Study procedures include answering a questionnaire, TB skin tests, blood samples, and a chest x-ray. Individuals with symptoms indicating TB will be asked to provide sputum samples. Individuals with TB will be involved in the study for up to 48 months; household contacts will be involved in the study for 12 months. The knowledge gained from this study will be used to improve tuberculosis control.