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CompletedNCT05464680ATB-COVIDUpdated Nov 19, 2025

Pulmonary Diffusion of Antibiotics in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia

An interventional study of blood sample and bronchoalveolar lavage in ARDS and SARS-CoV 2 Pneumonia, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Patients on mechanical ventilation (MV) following SARS-CoV-2 pneumonia frequently develop ventilator-associated pneumonia (VAP). The incidence of MVAP during SARS-CoV-2 infections ranges from 50 to nearly 90%. In addition, up to 80% of recurrences of VAP (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. This incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ARDS). The investigators hypothesize that during VAP, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in COVID-19 patients in relation to several factors characteristic of SARS-CoV-2 infection. This altered diffusion may explain the high number of recurrences of MVAP compared to non-COVID-19 patients.

02

Conditions studied

  • ARDS
  • SARS-CoV 2 Pneumonia

Keywords

  • mechanical ventilation
  • antibiotics diffusion
  • ARDS
  • SARS-CoV 2
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Patients positive to SARS-CoV 2

    Patients admitted to the ICU and placed on VM following SARS-CoV-2 pneumonia

    Other: blood sample and bronchoalveolar lavage

  • Sham comparator
    Patients negative to SARS-CoV 2

    Patients admitted to the ICU and placed on VM outside of SARS-CoV-2 pneumonia

    Other: blood sample and bronchoalveolar lavage

Interventions

  • Otherblood sample and bronchoalveolar lavage

    These patients are put on VM as part of their care and present a suspicion of a 1st episode of PAVM for which a microbiological sample is taken and a probabilistic antibiotic therapy is started with the PIP-TAZ association (D0). A plasma PIP-TAZ assay will be performed 48 hours after the start of antibiotic therapy with PIP-TAZ. Blood urea will be measured and a mini-LBA (performed with a Combicatheter®) will be performed to measure PIP-TAZ and urea in the ELF. On day 7 of the antibiotic therapy (last day of the planned antibiotic therapy), the same samples are taken and the same analyses are performed + bacteriology on the mini BAL. For patients for whom antibiotic therapy has been interrupted because of sterile samples, the samples taken at D7 will not be taken. The clinical outcome of the patient will then be recorded until D60.

06

What researchers measure

Primary outcomes

  1. Compare the pulmonary diffusion of piperacillin

    Dosage in the epithelial lining fluid

    Time frame: 48 hours following antibiotics administration

Secondary outcomes

  1. Pulmonary diffusion of tazobactam

    Dosage in the epithelial lining fluid

    Time frame: 48 hours following antibiotics administration

  2. Concentrations of piperacillin in effective pulmonary and plasma targets

    Piperacillin concentrations in Epithelial Lining Fluid

    Time frame: 48 hours following antibiotics administration

  3. Concentrations of piperacillin in effective pulmonary and plasma targets

    Piperacillin concentrations in plasma

    Time frame: 7 days following antibiotics administration

  4. Concentrations of tazobactam in effective pulmonary and plasma targets

    Tazobactam concentrations in Epithelial Lining Fluid

    Time frame: 7 days following antibiotics administration

  5. Concentrations of tazobactam in effective pulmonary and plasma targets

    Tazobactam concentrations in Epitehlial Lining Fluid and plasma separately at H48 and 7 days after initiation of antibiotic therapy

    Time frame: 48 hours following antibiotics administration

07

Study locations

1 site
  • Service Médecine Intensive Réanimation
    Marseille, 13015, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05464680
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jul 19, 2022
Start date
Nov 24, 2022
Primary completion
May 9, 2025
Completion
May 9, 2025
Last update
Nov 19, 2025

Study contacts

François Cremieux
study director · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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