Study of Household Environmental Sources and Their Link to Non-Tuberculous Mycobacterial Infections in People with Cystic Fibrosis

What this Trial Is About

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.

Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home