Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia
| Registry | NCT06602934, acronym HOMI-LUNG-HAP |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, single group, masking: none, other |
| Enrollment | 300 (Estimated) |
| Sponsor | Nantes University Hospital (Other) |
| Conditions | Hospital Acquired Pneumonia (HAP), Cardiovascular and Respiratory Disease |
| Interventions | Blood samples, Oropharyngeal swabs, ECG, Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration (Other) |
| Dates | start 2025-01-02, primary completion 2028-07-03 (estimated), completion 2029-01-01 (estimated), first posted 2024-09-19, last updated 2026-06-04 |
| Locations | 5 sites in France |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 inspiration | Comparator |
| 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 inspiration | Comparator |
| 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: ECG | Comparator |
| 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 |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: 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) * 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 Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Angers University Hospital | Angers | France | Not yet recruiting |
| Nantes University Hospital | Nantes | France | Recruiting |
| Rennes University Hospital | Rennes | France | Not yet recruiting |
| Rouen University Hospital | Rouen | France | Not yet recruiting |
| Toulouse University Hospital | Toulouse | France | Not yet recruiting |