ARDSATB-COVIDNCT05464680
Pulmonary Diffusion of Antibiotics in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia
A study testing blood sample and bronchoalveolar lavage in people with ARDS and SARS-CoV 2 Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, SARS-CoV 2 Pneumonia
- What is being tested?
- blood sample and bronchoalveolar lavage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2022to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- Patients for whom PIP-TAZ is administered as a discontinuous infusion.
- 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
- Patient with a second episode of PAVM.
- 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).
- Patient on ExtraCorporeal Membrane Oxygenation (ECMO) or ExtraCorporeal CO2 Removal (ECCO2R).
- Pregnant or breastfeeding women, patients under guardianship or trusteeship, deprived of liberty
- Patients who are moribund or for whom limitations of active therapies have been decided.
- Any condition, which in the opinion of the investigator, would not allow the implementation of the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Diffusion of Antibiotics During Mechanically Ventilated Pneumonia in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia
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.
- Conditions
- ARDS, SARS-CoV 2 Pneumonia
- Being tested
- blood sample and bronchoalveolar lavage
- Keywords
- mechanical ventilation, antibiotics diffusion, ARDS, SARS-CoV 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and bronchoalveolar lavageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients positive to SARS-CoV 2 | Experimental | Patients admitted to the ICU and placed on VM following SARS-CoV-2 pneumonia Receives: Other: blood sample and bronchoalveolar lavage |
| Patients negative to SARS-CoV 2 | Sham comparator | Patients admitted to the ICU and placed on VM outside of SARS-CoV-2 pneumonia Receives: Other: blood sample and bronchoalveolar lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the pulmonary diffusion of piperacillin
Dosage in the epithelial lining fluid
Measured: 48 hours following antibiotics administration
Secondary outcomes (5)
Pulmonary diffusion of tazobactam
Dosage in the epithelial lining fluid
Measured: 48 hours following antibiotics administration
Concentrations of piperacillin in effective pulmonary and plasma targets
Piperacillin concentrations in Epithelial Lining Fluid
Measured: 48 hours following antibiotics administration
Concentrations of piperacillin in effective pulmonary and plasma targets
Piperacillin concentrations in plasma
Measured: 7 days following antibiotics administration
Concentrations of tazobactam in effective pulmonary and plasma targets
Tazobactam concentrations in Epithelial Lining Fluid
Measured: 7 days following antibiotics administration
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
Measured: 48 hours following antibiotics administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start24 Nov 2022
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Cremieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464680
- Sponsor's protocol ID
- RCAPHM21_0415
- Other IDs
- ID-RCB
- Acronym
- ATB-COVID
- Status last verified
- Nov 2025
- First submitted
- 14 Jul 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Diffusion of Antibiotics During Mechanically Ventilated Pneumonia in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia
- ClinicalTrials.gov ID
- NCT05464680
- Acronym / sponsor ID
- ATB-COVID / RCAPHM21_0415
- Conditions
- ARDS, SARS-CoV 2 Pneumonia
- Keywords
- mechanical ventilation, antibiotics diffusion, ARDS, SARS-CoV 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 19 Jul 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients positive to SARS-CoV 2 | Experimental | Other: blood sample and bronchoalveolar lavagePatients admitted to the ICU and placed on VM following SARS-CoV-2 pneumonia |
| Patients negative to SARS-CoV 2 | Sham comparator | Other: blood sample and bronchoalveolar lavagePatients admitted to the ICU and placed on VM outside of SARS-CoV-2 pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Patients for whom PIP-TAZ is administered as a discontinuous infusion.
- 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
- Patient with a second episode of PAVM.
- 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).
- Patient on ExtraCorporeal Membrane Oxygenation (ECMO) or ExtraCorporeal CO2 Removal (ECCO2R).
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 sample and bronchoalveolar lavageThese 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. | Other | Patients negative to SARS-CoV 2, Patients positive to SARS-CoV 2 |
Primary outcome
Compare the pulmonary diffusion of piperacillin
Time frame: 48 hours following antibiotics administration
Dosage in the epithelial lining fluid
5 secondary outcomes
Pulmonary diffusion of tazobactam
Time frame: 48 hours following antibiotics administration
Concentrations of piperacillin in effective pulmonary and plasma targets
Time frame: 48 hours following antibiotics administration
Concentrations of piperacillin in effective pulmonary and plasma targets
Time frame: 7 days following antibiotics administration
Concentrations of tazobactam in effective pulmonary and plasma targets
Time frame: 7 days following antibiotics administration
Concentrations of tazobactam in effective pulmonary and plasma targets
Time frame: 48 hours following antibiotics administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
François Cremieux study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and bronchoalveolar lavage in people with ARDS and SARS-CoV 2 Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site 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 3 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the pulmonary diffusion of piperacillin (time frame: 48 hours following antibiotics administration). 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 19 Nov 2025.