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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pseudomonas sp (n=30)

Klebsiella sp (n=20)

Haemophilus sp (n=20)

E-coli sp (n=20)

Disqualifiers

Inability to provide informed consent

Pregnancy

Medical instability preventing ability to attend for regular study visits at baseline.

Trial population

Patients will be recruited from hospital chronic lung disease clinics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

170 Participants
are grouped into 1 trial group
Group A: Chronic lung disease

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years
3

Analysis of metagenomic resistome on exacerbation frequency in chronic lung disease

Time frame
2 years
4

Analysis of metagenomic resistome on disease severity in chronic lung disease

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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