Hospital Acquired Pneumonia (HAP)HOMI-LUNG-HAPNCT06602934
Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia
A study testing Blood samples, Oropharyngeal swabs and ECG in people with Hospital Acquired Pneumonia (HAP) and Cardiovascular and Respiratory Disease, run by Nantes University Hospital at 5 sites in France.
Trial summary
The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hospital Acquired Pneumonia (HAP), Cardiovascular and Respiratory Disease
- What is being tested?
- Blood samples, Oropharyngeal swabs and ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Jan 2025to 1 Jan 2029
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group A (patients with acute cardiac disease)
- Male or female
- Hospitalized for acute coronary syndrome for less than 7 days.
- Informed consent from the patient
- Person insured under a health insurance scheme
- Group B (patients with chronic cardiovascular disease)
Show all 25Show fewer
- Male or female,
- Undergoing coronary artery by-pass surgery
- Hospitalized in intensive care unit for \> 12 hours
- Informed consent from the patient
- Person insured under a health insurance scheme
- Group C (patients at risk of CVRD without chronic cardiovascular disease)
- Male or female,
- Familial high levels of cholesterol or triglycerides
- With no personal history of CVRD, with a recent negative cardiac exercise test (last test inferior to 12 months)
- Follow-up for lipid abnormalities at high risk of CVRD events
- Informed consent from the patient
- Person insured under a health insurance scheme
- Group D (patients with HAP)
- Male or female
- With one or more risk factors for CVD among:
- Age ≥ 65 years old Smoking, Abnormal lipidic levels, High blood pressure, Obesity, Diabetes mellitus, Chronic kidney disease
- Cured from mechanically ventilated HAP during the current hospitalization
- Informed consent from the patient or relatives
- Person insured under a health insurance scheme
Who cannot join
- Groups A, B, C and D
- Age <80 years old
- Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia; 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.
- Pregnant women, breastfeeding women.
- Adults under guardianship or trusteeship.
- Low probability of survival at day 28.
- o Groups A, B, C
- Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Not yet recruiting
Angers University Hospital
Angers
Sigismond LASOCKI, +33 2 41 35 36 35, silasocki@chu-angers.fr
Sigismond LASOCKI
- Recruiting
Nantes University Hospital
Nantes
Antoine ROQUILLY, +33 2 40 58 22 30, Antoine.roquilly@univ-nantes.fr
Cécile POULAIN
- Not yet recruiting
Rennes University Hospital
Rennes
Yoann LAUNEY, +33 2 99 28 24 56, yoann.launey@chu-rennes.fr
Yoann LAUNEY
- Not yet recruiting
Rouen University Hospital
Rouen
Emmanuel BESNIER, +33 2 32 88 89 90, Emmanuel.Besnier@chu-rouen.fr
Emmanuel BESNIER
- Not yet recruiting
Toulouse University Hospital
Toulouse
Fanny BOUNES, +33 5 61 32 27 99, bounes.f@chu-toulouse.fr
Fanny BOUNES
About this study
Official title: Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.
- Being tested
- Blood samples, Oropharyngeal swabs, ECG, Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration
- Keywords
- Hospital-acquired pneumonia, Cardiovascular and respiratory diseases, Respiratory microbiome
- Medical subject headings
- Healthcare-Associated Pneumonia, Respiration Disorders, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6 and M18 (only at inclusion for group C).
Oropharyngeal swabsOther
An oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18.
ECGOther
Performed at inclusion, M6 and M18
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspirationOther
Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration: These tests will be performed consecutively for 2 hours at inclusion M6 and M18. These tests will be performed to assess respiratory and cardiac function.
| Study group | Role | What they receive |
|---|---|---|
| Group A : Patients with acute major cardiovascular event | Other | Comparator Receives: Other: Blood samples; Other: Oropharyngeal swabs; Other: ECG; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration |
| Group B: Patients with severe chronic cardiovascular disease | Other | Comparator Receives: Other: Blood samples; Other: Oropharyngeal swabs; Other: ECG; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration |
| Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA | Other | Comparator Receives: Other: Blood samples; Other: Oropharyngeal swabs; Other: ECG |
| Group D: Patients cured of HAP | Experimental | Not described Receives: Other: Blood samples; Other: Oropharyngeal swabs; Other: ECG; Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) at 6 months
Measured: 6 months
Secondary outcomes (24)
Rate of events
Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death
Measured: Month 6 and Month 18
Rate of thrombo-embolic events
Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis
Measured: Month 6 and Month 18
Rate of patients with poor cardiorespiratory fitness
Poor tolerance defined as VO2max lower than the normal values for age
Measured: 6 Month
Long-term CVD progression
- Decrease in VO2max measured by cardiopulmonary exercise stress testing
- - Rates of CVD are defined as
- % patients with VO2max lower than normal values for age and sex.
- % patients with new rhythm cardiac alterations, of new repolarisation abnormality
Measured: Month 6 and Month 18
Rates of major respiratory events
Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality
Measured: Month 6 and Month 18
NYHA (New York Heart Association) classification
NYHA (New York Heart Association) classification of dyspnea
Measured: Month 6 and Month 18
mMRC (Modified Medical Research Council) Dyspnoea Scale
mMRC (Modified Medical Research Council) Dyspnoea Scale (Grade O to 4 : grade O = I only get breathless with strenuous exercise ; grade 4 : I am too breathless to leave the house or I am breathless when dressing/undressing)
Measured: Month 6 and Month 18
Rate of restrictive chronic respiratory distress
Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values
Measured: Month 6 and Month 18
Rate of obstructive chronic respiratory distress progression
Rate of obstructive chronic respiratory distress progression
Measured: Month 6 and Month 18
Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex
Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex
Measured: Month 6 and Month 18
Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex
Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex
Measured: Month 6 and Month 18
Rate of patients with secondary lower respiratory tract infection
Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray
Measured: Month 6 and Month 18
Rate of patients with non-respiratory infection
- Rates of patients with secondary lower respiratory tract infection defined as clinical signs of infection (fever, cough, hyperleukocytosis or leukopenia), with new infiltrate on Chest-X-Ray (performed as standard of care).
- Rates of patients with non-respiratory infection defined as pyelonephritis, septicemia, skin infection or others.
Measured: Month 6 and Month 18
Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27
Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27
Measured: Month 6 and Month 18
Glasgow Outcome Scale Extended values
Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury
Measured: Month 6 and Month 18
Brief Pain Inventory score
BPI score. This self-assessment questionnaire assesses the maind imensions of pain : intensity, functional disability, social and family repercussions and level of psychological distress (scale 0-10 : 0 = no pain , 10 = worst pain)
Measured: Month 6 and Month 18
Rates of patients with chronic pain
Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3
Measured: Month 6 and Month 18
Rates of patients with severe symptoms of anxiety
Rates of patients with severe symptoms of anxiety defined as HADS_a and HADS_d >=11
Measured: Month 6 and Month 18
Mean Satisfaction With Life Scale (SWLS) score
Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score
Measured: Month 6 and Month 18
Correlation between SWLS and EQ-5D-5L dimensions and utility scores
Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores
Measured: Month 6 and Month 18
SF(Short Form)-36 score
Patients' responses to the SF-36 to estimate the change in Health-Related Quality of Life (HRQoL) over time
Measured: Month 6 and Month 18
Mean QALYs (Quality-Adjusted Life-Years)
Mean QALYs (Quality-Adjusted Life-Years)
Measured: 18 months
EPICES (Evaluation of precariousness and health inequalities in health examination centers) score
Rate of socio-economical precarity defined as EPICES (Evaluation of precariousness and health inequalities in health examination centers) score values \> 30 at M6, 18 and M30
Measured: Month 6, Month 18 and Month 30
Modelisation of host-microbiome interactions
Modelisation of host-microbiome interactions
Measured: Month 0, Month 6 and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Jan 2025
- Primary completion3 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired Pneumonia (HAP)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602934
- Sponsor's protocol ID
- RC24_0112
- Acronym
- HOMI-LUNG-HAP
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
- ClinicalTrials.gov ID
- NCT06602934
- Acronym / sponsor ID
- HOMI-LUNG-HAP / RC24_0112
- Keywords
- Hospital-acquired pneumonia, Cardiovascular and respiratory diseases, Respiratory microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (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.
The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A : Patients with acute major cardiovascular event | Other | Other: Blood samples, Other: Oropharyngeal swabs, Other: ECG, Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspirationComparator |
| Group B: Patients with severe chronic cardiovascular disease | Other | Other: Blood samples, Other: Oropharyngeal swabs, Other: ECG, Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspirationComparator |
| Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA | Other | Other: Blood samples, Other: Oropharyngeal swabs, Other: ECGComparator |
| Group D: Patients cured of HAP | Experimental | Other: Blood samples, Other: Oropharyngeal swabs, Other: ECG, Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Group A (patients with acute cardiac disease)
- Male or female
- Hospitalized for acute coronary syndrome for less than 7 days.
- Informed consent from the patient
- Person insured under a health insurance scheme
Key exclusion criteria (8 listed)
- Groups A, B, C and D
- Age <80 years old
- Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia; 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.
- Pregnant women, breastfeeding women.
- Adults under guardianship or trusteeship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesFour blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6 and M18 (only at inclusion for group C). | Other | Group A : Patients with acute major cardiovascular event, Group B: Patients with severe chronic cardiovascular disease, Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA, Group D: Patients cured of HAP |
| Oropharyngeal swabsAn oropharyngeal swab will be taken to analyze patients\' upper airway microbiome at inclusion, M6 and M18. | Other | Group A : Patients with acute major cardiovascular event, Group B: Patients with severe chronic cardiovascular disease, Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA, Group D: Patients cured of HAP |
| ECGPerformed at inclusion, M6 and M18 | Other | Group A : Patients with acute major cardiovascular event, Group B: Patients with severe chronic cardiovascular disease, Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA, Group D: Patients cured of HAP |
| Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspirationCardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration: These tests will be performed consecutively for 2 hours at inclusion M6 and M18. These tests will be performed to assess respiratory and cardiac function. | Other | Group A : Patients with acute major cardiovascular event, Group B: Patients with severe chronic cardiovascular disease, Group D: Patients cured of HAP |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: 6 months
Major adverse cardiovascular events (MACE) at 6 months
24 secondary outcomes
Rate of events
Time frame: Month 6 and Month 18
Rate of thrombo-embolic events
Time frame: Month 6 and Month 18
Rate of patients with poor cardiorespiratory fitness
Time frame: 6 Month
Long-term CVD progression
Time frame: Month 6 and Month 18
Rates of major respiratory events
Time frame: Month 6 and Month 18
NYHA (New York Heart Association) classification
Time frame: Month 6 and Month 18
mMRC (Modified Medical Research Council) Dyspnoea Scale
Time frame: Month 6 and Month 18
Rate of restrictive chronic respiratory distress
Time frame: Month 6 and Month 18
Rate of obstructive chronic respiratory distress progression
Time frame: Month 6 and Month 18
Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex
Time frame: Month 6 and Month 18
Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex
Time frame: Month 6 and Month 18
Rate of patients with secondary lower respiratory tract infection
Time frame: Month 6 and Month 18
Rate of patients with non-respiratory infection
Time frame: Month 6 and Month 18
Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27
Time frame: Month 6 and Month 18
Glasgow Outcome Scale Extended values
Time frame: Month 6 and Month 18
Brief Pain Inventory score
Time frame: Month 6 and Month 18
Rates of patients with chronic pain
Time frame: Month 6 and Month 18
Rates of patients with severe symptoms of anxiety
Time frame: Month 6 and Month 18
Mean Satisfaction With Life Scale (SWLS) score
Time frame: Month 6 and Month 18
Correlation between SWLS and EQ-5D-5L dimensions and utility scores
Time frame: Month 6 and Month 18
SF(Short Form)-36 score
Time frame: Month 6 and Month 18
Mean QALYs (Quality-Adjusted Life-Years)
Time frame: 18 months
EPICES (Evaluation of precariousness and health inequalities in health examination centers) score
Time frame: Month 6, Month 18 and Month 30
Modelisation of host-microbiome interactions
Time frame: Month 0, Month 6 and Month 18
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 4 Jun 2026.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, Oropharyngeal swabs and ECG in people with Hospital Acquired Pneumonia (HAP) and Cardiovascular and Respiratory Disease, run by Nantes University Hospital at 5 sites in France.
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 25 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Antoine ROQUILLY (+33253482840, Antoine.roquilly@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: 6 months). 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 4 Jun 2026.