NCT07369414

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Research Center Borstel · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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 fibrosis. Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.

Detailed description

This multicenter, non-interventional case-control study investigates whether domestic environmental reservoirs-particularly household water systems-contribute to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). Approximately 120 CF patients from several centers in Germany will be enrolled, including 60 patients with a current or previous pulmonary NTM infection and 60 CF patients without known NTM infection as controls. Environmental samples (water, dust, and soil) will be collected from participants' households and analyzed for the presence of NTM using culture-based methods, PCR, and whole-genome sequencing. These findings will be compared between case and control households, and genetic similarity between environmental NTM isolates and available clinical isolates from the same patients will be assessed. In addition, standardized questionnaires will capture environmental and behavioral risk factors associated with NTM occurrence. The study is purely observational and relies on clinical data and isolates obtained through routine CF care, with no additional medical procedures for participants. Over a follow-up period of up to three years, newly occurring NTM infections in initially unaffected patients will be documented. The results aim to improve understanding of environmental exposure risks for NTM in CF and to provide evidence for future prevention strategies and potential guideline recommendations.

Conditions

• Cystic Fibrosis (CF)
• Mucoviscidosis
• Non-Tuberculous Mycobacteria
• Mycobacterium Abscessus Infection

Interventions

Type	Name	Description
OTHER	Multi-modal NTM diagnostic including PCR, WGS, culture	Environmental samples from participants' households (e.g., water, dust, and soil) will be collected and tested for the presence of NTM. Analyses will be performed using PCR, culture-based methods, whole-genome sequencing (WGS), and subsequent bioinformatic analyses. In addition, available clinical NTM isolates from previous or future routine diagnostics will be included. If genomic sequencing has not yet been performed for these isolates, retrospective molecular genetic analysis (e.g., by WGS) will be conducted within the study to enable comparison with environmental isolates.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

2 sites across 1 country: Germany