Investigating how antibiotics diffuse in the lungs of patients with ARDS after COVID-19 pneumonia
Pulmonary Diffusion of Antibiotics During Mechanically Ventilated Pneumonia in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia
This study is trying to see how well antibiotics work in the lungs of patients on ventilators for ARDS after COVID-19 pneumonia to help improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05464680 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients who are on mechanical ventilation due to acute respiratory distress syndrome (ARDS) following SARS-CoV-2 pneumonia. It aims to understand how the diffusion of intravenous antibiotics is altered in the lungs of these patients, which may contribute to the high rates of ventilator-associated pneumonia (VAP) recurrences. By analyzing blood samples and conducting bronchoalveolar lavage, the researchers hope to identify factors that affect antibiotic efficacy in this specific patient population. The findings could lead to improved treatment strategies for ARDS patients suffering from VAP.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are experiencing ARDS and require mechanical ventilation, particularly those with suspected first episodes of VAP.
Not a fit: Patients who are not on mechanical ventilation or those with contraindications to bronchoalveolar lavage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance antibiotic treatment protocols for patients with ARDS following COVID-19, potentially reducing the incidence of recurrent VAP.
How similar studies have performed: While the specific approach of this study may be novel, other studies have indicated that understanding antibiotic diffusion in ARDS patients can lead to improved treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Patient over 18 years of age 2. Patient has given consent or consent obtained from the trusted person if the patient is not capable of consenting, after informed consent. 3. Patient with ARDS 4. Patient requiring MV for ARDS (as defined by Berlin (15)), regardless of etiology (COVID-19 or other cause of ARDS) 5. Patient with suspected 1st episode of ARDS for which microbiological sampling is performed (bronchial aspiration, protected distal sampling (PDS), bronchoalveolar lavage (BAL)) 6. Patients who have received probabilistic antibiotic therapy within 24 hours of the microbiological sample, including piperacillin-tazobactam (PIP-TAZ) administered according to current recommendations. 7. Patient who is a beneficiary of or affiliated to a social security system Exclusion Criteria: 1. Patients for whom PIP-TAZ is administered as a discontinuous infusion. 2. Contraindication to the realization of a mini-LBA: patient whose respiratory state is too precarious for the realization of a mini-LBA for intra pulmonary antibiotics dosage (SpO2\<94% under FiO2 100% under VM), presence of a non drained pneumothorax, bronchial prosthesis, recent bronchial suture 3. Patient with a second episode of PAVM. 4. Patients with KDIGO stage ≥ 3 renal failure or extra-renal replacement therapy (creatinine measurement on the day of inclusion, performed as part of routine care). 5. Patient on ExtraCorporeal Membrane Oxygenation (ECMO) or ExtraCorporeal CO2 Removal (ECCO2R). 6. Pregnant or breastfeeding women, patients under guardianship or trusteeship, deprived of liberty 7. Patients who are moribund or for whom limitations of active therapies have been decided. 8. Any condition, which in the opinion of the investigator, would not allow the implementation of the study procedures.
Where this trial is running
Marseille
- Service Médecine Intensive Réanimation — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Sami Hraiech
- Email: sami.hraiech@ap-hm.fr
- Phone: 04 91 96 58 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.