RecruitingNCT07646691ClinicalTrials.gov record

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

Chronic Lung Diseases

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Observational
Phase: Not applicable / not listed
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 170 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

Pathway 1:

Prospective data collection will occur twice a year over a two-week period capturing attendees to chronic lung disease clinics in that period. No participant identifiable information will be recorded with a e-CRF capturing baseline demographics, medical history, clinical characteristics, treatment regimens, and microbiological findings and inputted into a secure online Redcap database. The end of the last 2 week period will be defined as the end of the study for pathway 1.

Pathway 2:

Clinical Visits and Sampling:

(i) Baseline visit All eligible individuals will undergo screening when clinically stable including clinical history/ examination, respiratory function testing (spirometry) and a severity assessment with the use of validated questionnaires (COPD assessment test (CAT), Bronchiectasis Health Questionnaire (BHQ)). Clinical information including microbiology cultures, the underlying lung disease and other medical conditions and medication history will be obtained from medical records. Microbiological isolates from clinical sputum sampling will be stored for further genomic analysis.

At the first study visit the following biological samples will be taken to address the study objectives:

sputum
nasal samples (Nasopharyngeal swab, synthetic absorptive matrix (SAM) sampling to sample nasal lining fluid and nasal brushings)
Exhaled breath
Venous blood (40mls)
Stool (remote stool sampling (performed at home and posted in) using secure bespoke collection kits)

(ii) Exacerbation monitoring and sampling: Participants that develop symptoms of acute viral infection or acute exacerbation will have the following sampling and clinical assessment as detailed above.

Early exacerbation sampling (\<48hrs of increased symptoms) (REMOTE STUDY VISIT from home)
Remote nasopharyngeal swab and sputum sampling with bespoke collection kits
Mid-exacerbation sampling (within 5 days of increased symptoms) (IN PERSON VISIT)
clinical assessment, spirometry, validated questionnaires (as per baseline)
sputum
nasal samples (Nasopharyngeal swab, SAM and nasal brushings)
Exhaled breath
Venous (40mls)
Stool (remote stool sampling using bespoke collection kits)

(iii) Stable longitudinal assessment: All participants will undergo further clinical visits similar to baseline at 6 monthly intervals over a 2 year period (as detailed above).

(iiii) At 6 monthly intervals throughout the 2 year period, air and surface swab samples will be taken from hospital high-traffic areas such as inpatient ward and outpatient clinic settings for analysis of presence of hospital environmental AMR reservoirs.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study population

Patients will be recruited from hospital chronic lung disease clinics.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not reported
Masking: Not reported

Chronic lung disease

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.