MAC Infection

Researchers are investigating biomarkers linked to the response to phage therapy in patients with refractory bacterial infections, including those with nontuberculous mycobacterial (NTM) lung disease. The study aims to find biological markers that indicate clinical, radiographic, or culture improvements after at least 6 to 8 weeks of bacteriophage treatment. This observational study is conducted by NYU Langone Health and focuses on understanding how phage therapy affects infection outcomes. Participants who have a positive match for their NTM bacterial isolate will receive mycobacteriophage treatment following a prescribed regimen. Blood and airway samples will be collected during follow-up visits from both those receiving phage therapy and those who do not, allowing comparison of biomarker changes such as airway microbiome shifts, gene expression, inflammatory markers, and neutralizing antibodies against phages. Throughout the study, participants will provide blood and leftover airway samples during their scheduled follow-ups. Researchers will monitor various biomarkers to correlate them with clinical signs, radiographic findings, and culture results indicating infection improvement. The primary outcome focuses on identifying biomarkers related to positive treatment response over a period of up to two years. Safety and antibody development will also be assessed to better understand phage therapy effects.

The Bronchiectasis Research Registry collects information from patients with non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) across many clinical centers. It aims to support collaborative research and help plan future clinical trials for these lung diseases, which are progressive and currently incurable. The registry also provides insights into the different types of Bronchiectasis and how the disease develops. Participants include adults over 18 with non-CF Bronchiectasis, with or without NTM, and those with NTM only. This observational registry gathers data from these patient groups to better understand their conditions. There are no study treatments; instead, the focus is on collecting and analyzing patient information over time. Participants will contribute by allowing researchers to collect clinical data about their condition. The main outcome is patient recruitment and data analysis through December 2050. There are no interventions, but ongoing data collection helps researchers study disease characteristics and patient outcomes. Participation may involve sharing medical history and other information to support research.

Researchers are evaluating a new diagnostic blood test for Non-Tuberculous Mycobacterial (NTM) infection in people with cystic fibrosis. This test measures the immune system's T cell response to the infection. The study aims to better understand how the body reacts to NTM in these patients by comparing those with and without infection. It is a multicenter case-control study focusing on T cell release of interferon-gamma as a marker of infection. The study involves one scheduled visit during routine cystic fibrosis care where a blood sample is taken. An additional 7 ml tube of blood will be collected to perform serology and culture tests. Patients are grouped based on positive or negative NTM serology and culture results. This approach allows researchers to assess cellular biomarkers linked to NTM infection. Participants will have their blood tested for the interferon-gamma release assay and T lymphocyte response during this single visit. The study measures the immune response to NTM antigens to provide more detailed diagnostic information than standard methods. The total participation involves just this one visit, which coincides with regular clinical care for cystic fibrosis.

Researchers are investigating treatments for Mycobacterium avium complex (MAC) lung infections, a growing public health concern caused by non-tuberculous mycobacteria. This trial compares two antibiotic regimens to evaluate whether azithromycin is not less effective than clarithromycin when combined with rifampicin and ethambutol, aiming to improve tolerance and treatment adherence in adult patients with fibrocavitary or nodular bronchiectatic forms of MAC lung disease. Participants will be randomly assigned to receive one of two treatment combinations: rifampicin, ethambutol, and clarithromycin (1000 mg daily in two doses), or rifampicin, ethambutol, and azithromycin (250 mg once daily). Treatment is administered daily for at least 12 months. The study is open-label and conducted across multiple centers in France, with medication compliance monitored through patient records. During the 12-month treatment period, participants will undergo regular monitoring including liver function tests, blood counts, monthly eye exams, and electrocardiograms. Pharmacokinetic studies will measure antibiotic levels in blood and cells at 1 and 6 months. Clinical, radiological, and microbiological assessments occur at baseline, 3, 6, and 12 months. Long-term follow-up up to 5 years will track adverse effects, relapses, and survival. The main outcome measured is sputum culture results at 6 months.

Researchers are conducting a registry study to enroll control participants without significant respiratory symptoms or radiographic abnormalities. These healthy volunteers, who visited Seoul National Hospital Healthcare System Gangnam Center for routine check-ups, will provide data that can be compared with other registries of various respiratory diseases such as Chronic Obstructive Pulmonary Disease, Asthma, and Lung Cancer. The study aims to understand mortality and hospitalization outcomes over a 20-year period. Participants in this observational study do not receive any intervention. They undergo baseline questionnaires, provide blood specimens, and share results from their health check-ups, including chest radiography. The study includes adults aged 19 to 90 years who have agreed to participate. No treatments or procedures are administered as part of the study. Throughout the study, participants will be monitored primarily for mortality over 20 years. Secondary outcomes include all-cause hospitalization, respiratory-specific hospitalization, and diagnosis of respiratory diseases within the same timeframe. Data collection relies on initial health information and long-term follow-up to track these outcomes, with no additional interventions or frequent study visits required.

Researchers are working to create a detailed patient registry for adults diagnosed with non-CF bronchiectasis and/or Nontuberculosis Mycobacteria (NTM). The purpose of this project is to collect complete clinical information and quality of life data to better understand these conditions. This observational study is sponsored by the University of Calgary and seeks to gather comprehensive data from patients aged over 18 years. The study includes adults with either non-CF bronchiectasis, with or without NTM, or those with NTM alone. Participants' clinical details and assessments of their quality of life will be entered into a centralized patient registry. There are no specific treatments or interventions being tested, as this is an observational data collection study. Participants will provide their health information to be recorded in the registry. This includes clinical data and quality of life evaluations. The main outcome measured is patient recruitment and data analysis related to NTM and bronchiectasis, with follow-up planned through December 2050. Participation involves sharing medical records and completing questionnaires over time to support research on these lung conditions.

Researchers are studying Mycobacterium avium complex (MAC) lung disease, a type of nontuberculous mycobacteria infection that has become more common worldwide. This observational study aims to understand how drug exposure and the minimum inhibitory concentration (MIC) of antimycobacterial drugs relate to treatment response. The study focuses on treatment outcomes, including culture conversion, lung function, radiology, and quality of life in adult patients with culture-positive MAC lung disease. Participants will receive standard treatment regimens containing macrolides, rifamycin, and ethambutol, following established international and Chinese guidelines. Respiratory samples will be collected regularly for mycobacterial culture and MIC testing. Blood samples for drug concentration measurement will be taken at one month after treatment starts, with more detailed sampling in some patients to develop pharmacokinetic models. Additional samples will be collected at six months for those with poor treatment response. Post-treatment visits at 6 and 12 months will monitor recurrence. Throughout the study, participants will undergo regular mycobacterial culture, lung function tests, CT scans, and quality-of-life questionnaires. Researchers will analyze drug exposure variables like peak plasma concentration and area under the curve, along with MIC values, to explore their association with treatment success. Treatment outcomes and adverse events will be recorded up to 18 months, and recurrence will be monitored up to 30 months after treatment completion. The total study duration includes baseline, treatment, and follow-up assessments.

Researchers are investigating whether household environmental sources, especially water systems, are linked to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). This observational case-control study includes about 120 CF patients from several centers in Germany, half with a current or past NTM lung infection and half without. The study aims to better understand how people with CF might be exposed to NTM at home and guide future prevention strategies. Environmental samples such as water, dust, and soil will be collected from participants' homes and tested for NTM using methods like culture, PCR, and whole-genome sequencing. These results will be compared between households of patients with and without NTM infections. Researchers will also compare environmental NTM to clinical isolates from the same patients and gather information on environmental and behavioral risk factors through questionnaires. The study is non-interventional and relies on data and samples collected during routine CF care. Participants will be followed for up to three years to document any new NTM infections in those initially without infection. The research team will assess the prevalence of NTM in home environments, differences between groups, and genetic similarities between environmental and patient samples. The study also looks at long-term outcomes and helps identify risk factors associated with NTM presence. There are no extra medical procedures for participants beyond routine care.

Researchers are studying whether changes in the airway microbiome are linked to pulmonary Non-tuberculous mycobacteria (NTM) disease in people suspected of having this condition. This observational study includes 200 participants and compares those with active NTM infection to those without based on sputum or lung sample cultures. The goal is to better understand the airway bacteria differences in NTM bronchiectasis. Participants will provide induced sputum and upper airway samples to analyze the airway microbiome. A subgroup will also undergo bronchoscopy to collect lower airway samples for comparison. The study groups include individuals with positive NTM cultures and controls with negative cultures. Procedures like bronchoscopy will be used to assess the lung microbiome more directly. During the study, participants will be assessed through airway sample collection and clinical evaluations. Researchers will use tools such as the Eating Assessment Tool (EAT-10), laryngoscopy, and the Reflux Symptom Index to evaluate symptoms related to airway reflux and swallowing difficulties. The primary outcome is to compare the airway microbiome between those with active pulmonary NTM disease and controls. The study includes safety and consent monitoring, with participation lasting according to study schedules.

Researchers are evaluating the effectiveness and safety of an exercise intervention program for patients with nontuberculous mycobacterial pulmonary disease (NTM-PD), a chronic lung infection that often affects people with structural lung diseases like COPD and bronchiectasis, as well as those without such conditions. The prevalence of NTM-PD is rising globally, posing public health concerns due to environmental exposure and chronic disease challenges. Pulmonary rehabilitation is important for chronic respiratory diseases, but data on exercise benefits for NTM-PD patients are limited. The study is a prospective, single-center, randomized, open-label trial with two groups. One group begins a six-week exercise program immediately after randomization, while the other starts the same program after a six-week delay. The program includes one day of hospital-based education and five days of home-based exercise each week, with exercises tailored to each patient's capacity, including aerobic, resistance, and flexibility training. Participants aged 40 to 80 with confirmed NTM-PD and respiratory symptoms will undergo baseline assessments including medical history, physical exams, six-minute walk test, quality of life questionnaires, body composition, handgrip strength, and lung function tests. These evaluations will be repeated after the exercise program and six months later to assess effects on maximal oxygen uptake and other health measures. Safety and adherence will be monitored throughout the study, which is sponsored by Yonsei University and scheduled through April 2027.