An Observational Study Into Antimicrobial Resistance in Patients With a Chronic Lung Disease

NCT07646691 | Not Yet Recruiting

• 1 other identifier: 174209
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

Antimicrobial resistance (AMR) refers to the ability of microorganisms like bacteria, viruses, fungi and parasites to resist the effects of antimicrobial drugs (such as antibiotics) which are widely used as treatment. AMR poses an escalating global health threat, contributing to difficult-to-treat infections associated with increased disease spread, disability and death, as well as a substantial economic burden. In chronic lung diseases, such as bronchiectasis, Cystic fibrosis or chronic obstructive lung disease (COPD), there is a higher risk of AMR due to the exposure to frequent or prolonged courses of antibiotics to treat recurrent lung infections and exacerbations (flares of the disease), to reduce lung inflammation or to control chronic infection within the lung with suppression of colonising microbes. Most data on AMR in chronic lung diseases derive from analysing pre-existing routinely collected health data collected on a national basis which is often incomplete. Hence a prospective study is crucial to better understand and address AMR in chronic lung diseases. Prospective studies follow patients forward in time, collecting data on outcomes and allowing researcher to observe the natural history of AMR development, monitor trends and evaluate interventions. This multicentre prospective study, as part of the European Respiratory Society (ERS) Clinical Research Collaboration on Antimicrobial Resistance in Lung Disease (CRC - AMR Lung), aims to investigate the patterns of AMR in chronic lung diseases through a fully anonymous registry alongside a prospective sub-cohort study tracking individuals with chronic lung disease and known colonisation with high-priority AMR pathogens (microorganisms). This study will enable analysis of prevalence and burden of AMR within chronic lung disease alongside understand the genetic drivers of resistance, the link between the microbial genotype and antimicrobial resistance and how transmission of resistance occurs in chronic lung disease.

Conditions

Chronic Lung Diseases

Keywords

antimicrobial resistance; chronic lung disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of antimicrobial resistant specific high-priority AMR pathogens in chronic lung disease

  2 years

Secondary Outcomes (4)

• Antimicrobial susceptibility pattern of high-priority AMR pathogens in chronic lung disease

  2 years

• Whole genome sequencing genotype-phenotype correlation of high-priority AMR pathogens in chronic lung disease

  2 years

• Analysis of metagenomic resistome on exacerbation frequency and disease severity in chronic lung disease

  2 years

• Genomic transmission dynamics of high priority AMR pathogens in chronic lung disease

  2 years

Study Arms (1)

Chronic lung disease

Patients with chronic lung disease who are colonised with a high priority antimicrobial resistant pathogen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from hospital chronic lung disease clinics.

You may qualify if:

• Presence of an underlying chronic lung disease (e.g. Bronchiectasis, COPD) stratified by colonisation status:
• Pseudomonas sp (n=30)
• Klebsiella sp (n=20)
• Haemophilus sp (n=20)
• E-coli sp (n=20)
• Stenotrophomonas sp (n=20)
• Staphylococcus sp (n=20)
• Other chronic colonisation (n=20)
• Not colonised with any bacterial pathogen (n=20)

You may not qualify if:

• Inability to provide informed consent
• Pregnancy
• Medical instability preventing ability to attend for regular study visits at baseline.

Sponsors & Collaborators

• Imperial College London: lead

Biospecimen

Retention: SAMPLES WITH DNA

Bloods, Sputum, Faeces, Nasal (including swab, synthetic absorptive matrix, and brushings)

Central Study Contacts

Anand Shah

CONTACT

0044 20 7352 8121; s.anand@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share