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Mycobacterium Infections clinical trials

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NCT ID: NCT02393586 Completed - Tuberculosis Clinical Trials

Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

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

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.

NCT ID: NCT02389322 Completed - Tuberculosis Clinical Trials

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 on Healthy People Aged 18-65

IIb-healthy
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The investigators select 500 subjects who meet the standard and are considered as study population I. Do specific gamma-interferon detection before the skin test, then inject intradermally with two dosage ESAT6-CFP10 and Tuberculin purified protein derivative (TB-PPD) at different arm of the same subject and get 192 participants whose three kinds of detection result are all negative and are considered as study population II.Then,they are immune to the Bacillus Calmette-Guerin (BCG) vaccine or the placebo of the BCG. Do specific gamma-interferon detection before the skin test, then inject intradermally with two dosage ESAT6-CFP10 and TB-PPD at different arm of the same subject 12 weeks after immunity.Negative rate of ESAT6-CFP10 after vaccination BCG as the main index , evaluate the specificity of different doses of ESAT6-CFP10, and conform the optimal dose of ESAT6-CFP10.

NCT ID: NCT02387242 Suspended - Tuberculosis Clinical Trials

Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers

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

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).

NCT ID: NCT02355015 Recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections

Start date: March 2014
Phase: N/A
Study type: Observational [Patient Registry]

The study aims to address the following aims 1. To provide an overview of the epidemiology of the patients who are managed in the Singapore General Hospital for NTM infections. 2. To evaluate the medical care of patients in the institution with regards to the type of medical and/or surgical treatment received and specifically, the antibiotic regime and duration administered. 3. A longitudinal follow up which will allow an assessment of our care and patient outcome in this population cohort

NCT ID: NCT02344004 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone

CONVERT
Start date: May 27, 2015
Phase: Phase 3
Study type: Interventional

A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC) that were refractory to treatment. Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.

NCT ID: NCT02340897 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

Start date: December 2014
Phase: N/A
Study type: Observational

The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.

NCT ID: NCT02336542 Completed - Tuberculosis Clinical Trials

Phase IIb Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Start date: November 2014
Phase: Phase 2
Study type: Interventional

96 TB subjects and 96 non-TB subjects with lung disease who all meet the standard are divided into different groups through a randomized, blind methods.Every subject inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same person.Specific γ- IFN(gamma interferon) detection is needed before the injection.Evaluate the sensitivity (positive coincidence rate) ,the specificity (negative coincidence rate) and the coincidence rate of ESAT6-CFP10 in the tuberculosis patients and non-tuberculosis patients with lung diseases, and determine the optimal dose of ESAT6-CFP10 for clinical auxiliary diagnosis of tuberculosis.

NCT ID: NCT02225158 Terminated - Clinical trials for Latent Tuberculosis Infection

Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth Infection

Start date: August 15, 2014
Phase: N/A
Study type: Observational

Background: Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It is caused by a bacteria that enters through the lungs and can spread elsewhere in the body. People with latent TB have the bacteria that lie dormant but can become active and cause disease. These people are offered treatment to prevent development of active TB. Worldwide, a lot of people with LTBI also have a parasitic worm called a helminth that can stay in the gut or the blood. These parasites can affect the immune system and cause diseases like TB to become worse. Researchers want to see how helminth infection makes it harder for people to fight TB infection. Objectives: - To study how the immune system of people with latent tuberculosis infection (LTBI) acts to prevent development of active TB. Also, to study how helminth infection might affect this immune response. Eligibility: - Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB Gold. - No evidence of infections like Hepatitis or HIV - Pregnant subjects and subjects taking medications that suppress the immune system are not eligible. - Have not received prior treatment for LTBI. Participants might be still eligible if prior treatment for active TB has been received Design: Screening phase: - Participants will be screened with medical history, physical exam, and blood tests for other infections/conditions which might affect the immune system. They will have testing for active TB i.e. blood testing as well as testing of their spit, scans and X-rays. Baseline phase: - Only eligible participants will be entered into the study. - Participants will have interviews, medical history, and physical exam. - Blood will be drawn from an arm vein for testing. - Participants will collect stool samples at home for 3 days in a row to test for helminth infection.. - Participants may have apheresis. Blood cells are removed by needle. They pass through a separator machine which returns everything but the cells back to the participant. - Participants may have procedures at the start and end of the study that let researchers look into the lungs and collect cells. Study phase, about 2 years: - All participants will be offered treatment for LTBI which lasts 6-9 months. - Participants being treated for LTBI will have about 11 study visits. They will visit monthly for 9 months while on treatment, then 6 and 12 months after treatment. - Participants not eligible/refusing treatment for LTBI will be made aware of active TB, then have 3 other visits, about 6, 12, and 24 months after the baseline visit. - Participants who have helminth infection will receive appropriate treatment. - All participants will have blood drawn at each visit.

NCT ID: NCT02198079 Completed - Cystic Fibrosis Clinical Trials

A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida

Start date: March 2010
Phase: N/A
Study type: Observational

To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric patients with cystic fibrosis in the State fo Florida. HYPOTHESIS: There is high prevalence of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest of the country.

NCT ID: NCT02153034 Active, not recruiting - Buruli Ulcer Clinical Trials

Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer

Buruli_Path
Start date: May 2013
Phase: N/A
Study type: Observational

Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to 15 years. Access to treatment is limited and many cases present late. There have been major advances in understanding the mechanism of disease together with improved diagnosis and management. The aim of the proposed studies is to identify markers predictive of a rapid response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions and oedematous lesions in Mu disease. Infection with Mu results in a nodule under the skin which enlarges and breaks down to form an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better if the treatment could be shortened. Our previous studies suggest this may be possible. Therefore a wide range of tests will be investigated in order to identify markers for people in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of toxin in the skin. During antibiotic treatment the rate of healing will be measured to find out which markers are the most reliable. In some patients new areas of inflammation develop despite treatment and this is called a paradoxical reaction. The immune response to Mu will be investigated serially during antibiotic treatment to investigate the cause of paradoxical reactions. About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will study the amount of Mu toxin produced by the strain of Mu cultured from patients with this form of the disease. Hypothesis - Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with treatment will have associated predictive viability or serum biomarkers. - Buruli ulcer patients with oedematous disease are associated with larger amounts of mycolactone and viable organisms