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Mycobacterium Infections clinical trials

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NCT ID: NCT06418711 Not yet recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

ICoN-1
Start date: June 2024
Phase: Phase 3
Study type: Interventional

This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to Guideline-based therapy (GBT).

NCT ID: NCT06409572 Not yet recruiting - Tuberculosis Clinical Trials

Study of GeneXpert Mycobacterium Tuberculosis/ Rifampicin (MTB/RIF) Versus the Routine Methods for Detection of Mycobacterium Tuberculosis

Start date: June 2024
Phase:
Study type: Observational

1. Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen (LJ) media culture to choose the best available test for the diagnosis of TB. 2. To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.

NCT ID: NCT06266442 Recruiting - Clinical trials for Respiratory Tract Diseases

M. Avium WGS During Mav-PD Treatment

Start date: May 13, 2024
Phase:
Study type: Observational

This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere. The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection.

NCT ID: NCT06262282 Enrolling by invitation - Cystic Fibrosis Clinical Trials

Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria

POSTSTAMP
Start date: February 5, 2024
Phase:
Study type: Observational

About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year.

NCT ID: NCT06253715 Not yet recruiting - Tuberculosis Clinical Trials

Shortened Regimen for Drug-susceptible TB in Children

SMILE-TB
Start date: September 30, 2024
Phase: Phase 3
Study type: Interventional

While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.

NCT ID: NCT06185166 Recruiting - Clinical trials for Non-Tuberculous Mycobacteria

State of Play of Non-tuberculous Mycobacteria in Alsace

Mycoba
Start date: December 5, 2022
Phase:
Study type: Observational

Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date. As an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness. There is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.

NCT ID: NCT06178913 Recruiting - Clinical trials for Nontuberculous Mycobacteria

Exercise Intervention in Patients With Nontuberculous Mycobacterial Pulmonary Disease

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

The study goal is to develop exercise intervention methods to improve the prognosis and quality of life of patients with non-tuberculous mycobacterial lung disease and to confirm the effectiveness of exercise intervention. This prospective study is scheduled to be conducted as a pre-post single-arm feasibility trial, targeting a total of 50 subjects.

NCT ID: NCT06155747 Recruiting - Clinical trials for Healthcare Associated Infection

Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)

C
Start date: March 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to facilitate standardized nontuberculous mycobacteria (NTM) outbreak investigations in healthcare centers. The main questions it aims to answer are: - Are respiratory NTM isolates identified as having membership in a suspected healthcare outbreak highly related based on whole genome sequencing? - Does epidemiologic investigation support healthcare-associated patient-to-patient NTM transmission? - Does healthcare environmental sampling support healthcare-associated NTM acquisition? If healthcare-associated NTM outbreaks are suspected, participants identified as having membership in a cluster of highly-related NTM infections will complete a demographic questionnaire.

NCT ID: NCT06062238 Recruiting - Tuberculosis Clinical Trials

Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults

Start date: March 5, 2024
Phase: Phase 3
Study type: Interventional

The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA-Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.

NCT ID: NCT06004037 Active, not recruiting - Clinical trials for Nontuberculous Mycobacterium Infection

Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex

Start date: January 16, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease