Chronic Lung DiseasesPRESIDENCT07646691
An Observational Study Into Antimicrobial Resistance in Patients With a Chronic Lung Disease
An observational study of Chronic Lung Diseases, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lung Diseases
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from hospital chronic lung disease clinics.
Who may be able to join
- 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)
Show all 9Show fewer
- Staphylococcus sp (n=20)
- Other chronic colonisation (n=20)
- Not colonised with any bacterial pathogen (n=20)
Who cannot join
- Inability to provide informed consent
- Pregnancy
- Medical instability preventing ability to attend for regular study visits at baseline.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Study of Antimicrobial RESIstance in Chronic Lung DiseasE
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.
Read more
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 detailed 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.
- Conditions
- Chronic Lung Diseases
- Keywords
- antimicrobial resistance, chronic lung disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic lung disease | Patients with chronic lung disease who are colonised with a high priority antimicrobial resistant pathogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of antimicrobial resistant specific high-priority AMR pathogens in chronic lung disease
Measured: 2 years
Secondary outcomes (5)
Antimicrobial susceptibility pattern of high-priority AMR pathogens in chronic lung disease
Measured: 2 years
Whole genome sequencing genotype-phenotype correlation of high-priority AMR pathogens in chronic lung disease
Measured: 2 years
Analysis of metagenomic resistome on exacerbation frequency in chronic lung disease
Measured: 2 years
Analysis of metagenomic resistome on disease severity in chronic lung disease
Measured: 2 years
Genomic transmission dynamics of high priority AMR pathogens in chronic lung disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Shah, Principal investigator, Imperial College LondonAran Singanayagam, Principal investigator, Imperial College LondonRaju Misra, Principal investigator, UKHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646691
- Sponsor's protocol ID
- 174209
- Acronym
- PRESIDE
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can apply to the ERS CRC for anonymised data access
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Antimicrobial RESIstance in Chronic Lung DiseasE
- ClinicalTrials.gov ID
- NCT07646691
- Acronym / sponsor ID
- PRESIDE / 174209
- Conditions
- Chronic Lung Diseases
- Keywords
- antimicrobial resistance, chronic lung disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic lung disease | – | –Patients with chronic lung disease who are colonised with a high priority antimicrobial resistant pathogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from hospital chronic lung disease clinics.
Key inclusion criteria (9 listed)
- Presence of an underlying chronic lung disease (e.g. Bronchiectasis, COPD) stratified by colonisation status:
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Pregnancy
- Medical instability preventing ability to attend for regular study visits at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of antimicrobial resistant specific high-priority AMR pathogens in chronic lung disease
Time frame: 2 years
5 secondary outcomes
Antimicrobial susceptibility pattern of high-priority AMR pathogens in chronic lung disease
Time frame: 2 years
Whole genome sequencing genotype-phenotype correlation of high-priority AMR pathogens in chronic lung disease
Time frame: 2 years
Analysis of metagenomic resistome on exacerbation frequency in chronic lung disease
Time frame: 2 years
Analysis of metagenomic resistome on disease severity in chronic lung disease
Time frame: 2 years
Genomic transmission dynamics of high priority AMR pathogens in chronic lung disease
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Researchers can apply to the ERS CRC for anonymised data access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anand Shah principal investigator
Imperial College London
Aran Singanayagam principal investigator
Imperial College London
Raju Misra principal investigator
UKHSA
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Diseases, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anand Shah (0044 20 7352 8121, s.anand@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antimicrobial resistant specific high-priority AMR pathogens in chronic lung disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.