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Mycobacterium Infections clinical trials

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NCT ID: NCT05926245 Completed - Clinical trials for Glutathione-cyclodextrin Complex Absorption

Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection

Start date: July 11, 2022
Phase: Phase 1
Study type: Interventional

The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure. GOAL: Confirm therapeutic level of glutathione following topical transdermal application. HYPOTHESIS: The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80%. AIM: Determine a non-invasive way to increase glutathione levels in the plasma and blood cells. This aim will be accomplished as follows: STEP 1: We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine (NAC) supplementation. STEP 2: Determine baseline levels of GSH, free radicals and cytokines through analysis of venipuncture blood draws. STEP 3: Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen. Measure the levels of GSH, free radicals and cytokines after 1 hour, 4 hour and 72 hours.

NCT ID: NCT05354583 Completed - Clinical trials for Nontuberculous Mycobacterial Pulmonary Infection

Treatment Outcome Between Mycobacterium Abscessus Infection in Chronic Lung Disease and Acquired Interferon-gamma Autoantibody Syndrome

Start date: June 15, 2022
Phase:
Study type: Observational

The treatment outcome of Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has not been well studied. Investigators will perform a retrospective and prospective cohort study to determine the treatment outcome of Mycobacterium abscessus infection in patients with acquired interferon-gamma autoantibody syndrome compared with the infection in patients with chronic lung disease which is known to be the most common group of infection and have high rates of treatment failure. Investigators hypothesized that Mycobacterium abscessus infection in acquired interferon-gamma autoantibody syndrome has better outcome than infection in chronic lung disease.

NCT ID: NCT05294146 Completed - Clinical trials for Nontuberculous Mycobacterial Diseases

Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease

C-LOAD
Start date: February 14, 2022
Phase: Phase 2
Study type: Interventional

Clofazimine (CFZ) is a promising drug for the treatment of NTM diseases. CFZ is highly active in vitro against M. abscessus and M. avium, the most common NTM pathogens, and shows synergy with macrolides and amikacin. The results from limited clinical studies with CFZ-based treatment regimens are promising. CFZ is currently considered an alternative drug for patients with M. avium complex infections, who are intolerant of first-line drugs. CFZ is a first-line oral drug for treatment of M. abscessus infections. CFZ might prove to be a cornerstone in NTM treatment, but its optimal dosage is not known. The current dose for adults is 100 mg oncedaily. However, due to the complex pharmacokinetics (PK) of CFZ - it is highly protein bound, extremely lipophilic and accumulates in fatty tissues resulting in a long elimination half-life of ~30 days - it takes several months before steady state, and presumably effective, concentrations are achieved. With the use of a loading dose regimen concentrations similar to those at steady state could be reached faster, possibly leading to improved early treatment efficacy. The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases. It will be an explorative, single-center, one-arm, open label, pharmacokinetic study. A number of 10 patients with pulmonary or extrapulmonary NTM disease will be included. Patients will receive a loading dose regimen of 300 mg once daily for 4 weeks and will then continue with a standard dose of 100 mg once daily until a total 4 months of treatment with CFZ. The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once daily, in adult patients with pulmonary or extrapulmonary NTM disease

NCT ID: NCT04884308 Completed - Cystic Fibrosis Clinical Trials

Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.

NCT ID: NCT04874948 Completed - Tuberculosis Clinical Trials

Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment

Start date: September 21, 2021
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects

NCT ID: NCT04718571 Completed - Geneva Area Clinical Trials

An Ecological Analysis of Nontuberculous Mycobacteria in the Geneva Area (2015-2020)

Start date: August 1, 2020
Phase:
Study type: Observational

Prevalence of NTM diseases has been increasing regularly over the past 30 years in industrialized countries Although NTM are identified worldwide, there are important geographical disparities as to the relative prevalence of NTM species There are no data covering the ecology of NTM in Switzerland. Because of the progressive increase in NTM clinical cases in area Geneva(as noted in other industrialized countries), reporting the specific NTM distribution is important and relevant. In this study, the investigators aimed to: 1/ describe the relative prevalence of NTM species in clinical samples analyzed in the Geneva area, covering ca 500'000 inhabitants over a 5-year period; 2/ determine how many culture positive patients were treated; and 3/ specify the clinical sites involved.

NCT ID: NCT04685720 Completed - Cystic Fibrosis Clinical Trials

A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients

Start date: December 7, 2020
Phase: N/A
Study type: Interventional

The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.

NCT ID: NCT04677543 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ARISE
Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.

NCT ID: NCT04556981 Completed - Clinical trials for Human Immunodeficiency Virus

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV

MESA-TB
Start date: November 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).

NCT ID: NCT04429256 Completed - Clinical trials for Mycobacterium Chimaera Infections

Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera

Start date: April 10, 2020
Phase:
Study type: Observational

Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices. So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.