Clinical trials: Non-Tuberculous Mycobacteria Pulmonary Disease
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Pulmonary NTM infection is recognized as one of the most challenging infections to treat among people with cystic fibrosis (PwCF), notable for prolonged treatment courses and often poor response to therapy.
- Trial name
- pHALT NTM (NCT05686837)
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis, Atypical Mycobacterium Infection
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis. II. Compare the clinical course of patients with negative versus positive cultures.
- Trial name
- NCT00004296
- Volunteers
- 1,000 people
- Sponsor
- National Center for Research Resources (NCRR)
Lung Cancer, Small Cell Lung Cancer
A Multicenter Clinical Trial of Sputum DNA Testing for Lung Cancer in China
The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose lung cancer by comparing with clinical standard method…
- Conditions
- Lung Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma
- Trial name
- NCT05337163
- Testing
- Diagnostic Test: Sputum DNA methylation analysis, chest CT or pathological examination
- Where
- China
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
Cough, COPD
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
This study pretends to evaluate the potential use of Hyfe Cough Tracker (Hyfe) to screen for, diagnose, and support the clinical management of patients with respiratory diseases, while enriching a dataset of disease-specific…
- Conditions
- Cough, COPD, GERD, Asthma
- Trial name
- NCT05042063
- Testing
- Hyfe Cough Tracker, Hyfe Air
- Where
- Spain
- Volunteers
- 616 people, healthy volunteers welcome
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease
Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
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…
- Conditions
- Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection, Mycobacterium Infections
- Trial name
- POSTSTAMP (NCT06262282)
- Testing
- mycobacteriophage
- Where
- 18 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Jewish Health
Cystic Fibrosis, Nontuberculous Mycobacterium Infection
Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis
Sources of NTM infection and modes of transmission among CF patients are poorly understood. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers.
- Trial name
- HALTNTM (NCT04024423)
- Testing
- Epidemiologic investigation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis
Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of NTM disease has been identified as one of…
- Trial name
- PREDICT (NCT02073409)
- Where
- 19 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Jewish Health
Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to…
- Conditions
- Mycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection, Non-Tuberculous Mycobacterial (NTM) Infections, Non-Tuberculous Mycobacteria Pulmonary Disease
- Trial name
- FORMaT-EVOLVE (NCT07485010)
- Testing
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Ceftriaxone for Injection, Amoxicillin
- Volunteers
- 300 people
- Sponsor
- The University of Queensland
Non - Tuberculosis Mycobacteria Lung Disease
NTM-LD Treatment Based on GenSeizer Characteristic Gene Capture Strategy
Treatment of non - tuberculosis mycobacteria lung disease is challenging. The current treatment used is from 2007 American Thoracic Society guidelines recommended antibiotic combination therapy, which is lack of validation of…
- Trial name
- NCT03224065
- Testing
- Genotype detected through GenSeizer high-throughput gene capture technology
- Where
- China
- Volunteers
- 246 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Cystic Fibrosis
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.
- Trial name
- NCT02372383
- Testing
- Ethambutol, Rifampin, Azithromycin
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Cystic Fibrosis
Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination.
- Trial name
- CIMENT (NCT03312075)
- Testing
- Sputum and blood samples
- Where
- 14 sites in France
- Volunteers
- 848 people
- Sponsor
- University Hospital, Brest
Cystic Fibrosis (CF), Mucoviscidosis
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households
This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic…
- Conditions
- Cystic Fibrosis (CF), Mucoviscidosis, Non-Tuberculous Mycobacteria, Mycobacterium Abscessus Infection
- Trial name
- NTMecoCF (NCT07369414)
- Testing
- Multi-modal NTM diagnostic including PCR, WGS, culture
- Where
- 2 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Research Center Borstel
Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation
Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt)
The goal of this observational study is to support U.S. healthcare centers in determining if they may have an NTM outbreak among patients receiving care at the healthcare center.
- Conditions
- Nontuberculous Mycobacterial Pulmonary Infection, Outbreak Investigation, Healthcare Associated Infection, Mycobacterium Infections
- Trial name
- TrANsMIt (NCT06155747)
- Testing
- Epidemiologic investigation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of North Carolina, Chapel Hill
Tuberculosis
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
The goal of this Phase II, multicenter, open-label, randomized controlled trial is to evaluate the efficacy and safety of short-course treatment regimens for children with non-severe, drug-susceptible pulmonary tuberculosis.
- Trial name
- NCT07893444
- Testing
- 4-month FDC-based regimen, 3-month BDCZ regimen, Standard 6-month treatment regimen
- Where
- 13 sites in China
- Volunteers
- 90 people
- Sponsor
- Huashan Hospital
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development
Active Tuberculosis, Latent Tuberculosis Infection
Performance Evaluation of the VIDAS TB-IGRA Assay.
This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection.
- Conditions
- Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
- Trial name
- NCT04048018
- Testing
- Blood draw and IGRA test
- Where
- 24 sites in United States, Brazil and 7 more
- Volunteers
- 2,401 people, healthy volunteers welcome
- Sponsor
- BioMérieux
Mycobacterium Infections, Nontuberculous, Mycobacteria, Atypical
Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
The proposed study will assess the efficacy, safety and tolerability of once daily dosing of Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC) mycobacterial multi-drug regimen in accordance…
- Trial name
- NCT03038178
- Testing
- LAI plus multi-drug regimen
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kevin Winthrop
Cystic Fibrosis
PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis
Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM disease has been identified as one of the…
- Trial name
- PATIENCE (NCT02419989)
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- National Jewish Health
Cystic Fibrosis, Pediatrics
A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida
To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric patients with cystic fibrosis in the State fo Florida.
- Trial name
- NCT02198079
- Testing
- Sputum
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Miami
Tuberculosis
Improving the Outcomes of Children With Tuberculosis Through Innovative Diagnostics and Treatment Monitoring
This study aims at identifying and evaluating novel diagnostic methods for children evaluated for respiratory tuberculosis. The investigators will use alternative samples like stool, urine, and masks to diagnose children with…
- Trial name
- RoGer Pedi (NCT06815588)
- Where
- Romania
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Research Center Borstel