Pulmonary SepsisIDASTNCT06956053
Personalized Optimization of Antibiotic Therapy in Pulmonary Sepsis Critically Ill Patients Through Application of Rapid Microbiological Diagnostic Technologies and Pharmacokinetic/Pharmacodynamic Modelling
A study testing Rapid ID/AST method and Conventional biological methods in people with Pulmonary Sepsis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Severe community-acquired and nosocomial pneumonia are associated with substantial morbidity and mortality. Early and appropriate antimicrobial therapy (AAT) is consistently the most effective intervention for reducing mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Sepsis
- What is being tested?
- Rapid ID/AST method and Conventional biological methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2025to 30 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized in ICU
- 18 years of age or older
- With a pulmonary sepsis defined a s documented or suspected acute pulmonary infection (nosocomial and community-acquired pneumonia) and a SOFA score >2.
- Written Informed consent from the patient whenever possible or written ascent from next of kin whenever present at inclusion. When a patient would not be capable of consenting prior to randomization, his/her deferred consent will be gotten.
Who cannot join
- COVID-19 patients
- Severe anaphylactic beta-lactam allergy
- First measurements of prescribed antibiotic concentration (TDM) not possible within 24 hr after randomization
- Pregnancy or lactation
- Any decision of limitation of care
- Pre-existing medical condition with a life expectancy of less than 3 months
- Absence of affiliation to social security
- Patient under guardianship, curatorship and deprived of liberty
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Severe community-acquired and nosocomial pneumonia are associated with substantial morbidity and mortality. Early and appropriate antimicrobial therapy (AAT) is consistently the most effective intervention for reducing mortality. Cure is most likely when pharmacokinetic (PK) / pharmacodynamics (PD) targets associated with maximum antibiotic (ABX) activity are achieved. However, the process of optimizing antibiotic therapy for critically ill patients remains a complicated challenge.
A key issue is pathogen identification (ID) with subsequent antibiotic susceptibility testing (AST) results which allow for selection of AAT. Standard laboratory procedures typically require 2-3 days to provide ID and AST results. Optimal ABX dosing/dosing intervals depend in large part on PK properties in individual patients, and antibacterial effects on the infecting bacteria (PD). Alterations in the primary PK parameters, namely volume of distribution (Vd) and clearance (CL), are commonly observed, and are the most influential parameters in determining ABX dosing and exposure. ABX dosing/dosing intervals that do not account for these features are likely to lead to suboptimal ABX exposure and therapeutic failures. Because of 48-72-hours delays in ID/AST, initial treatment is frequently inappropriate in coverage, unnecessarily broad in spectrum, and/or suboptimal in dosing.
Read more
Methods for rapid bacterial growth, ID, AST and minimum inhibitory concentration (MIC) identification were developed and are capable of quantitative ID in 1-2 hours and major AST in 6-8 hours using clinical specimens. Rapid ID of the infecting pathogen and its individual AST could significantly impact the early selection of AAT and, combined with therapeutic drug monitoring data, could be used to calculate optimized dosing regimens that are personalized for the patient in order to achieve appropriate PK/PD targets.
Hypothesis: Application of these rapid ID/AST systems, together with prospective PK/PD monitoring of antibiotic plasma concentrations, will significantly shorten time from "sample to answer" for pathogen ID/AST, enhance personalized prescribing of antibiotics, optimize the time to targeted effective and AAT, and result in decreased treatment failure.
- Conditions
- Pulmonary Sepsis
- Being tested
- Rapid ID/AST method, Conventional biological methods
- Keywords
- Pulmonary sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid ID/AST methodDiagnostic test
- BioFire® Film Array® Blood Culture Identification 2 BCID2 panel, bioMérieux/BioFire Diagnostics, CE marked (FDA cleared)
- BioFire® FilmArray® Pneumonia Panels, CE marked (FDA cleared)
- SPECIFIC REVEAL® Rapid Antimicrobial Susceptibility test (AST) System, bioMérieux/Specific Diagnostics, CE-IVD and -IVDR marked
Conventional biological methodsDiagnostic test
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Rapid ID/AST method | Experimental | Not described Receives: Diagnostic Test: Rapid ID/AST method |
| Conventional microbiological methods | Active comparator | Not described Receives: Diagnostic Test: Conventional biological methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment failure
It includes treatment failure that occurred early (≤72 hours) or late (>72 hours), or at both times.
Measured: Up to 10 days after inclusion
Secondary outcomes (21)
Time to availability of pathogen
ID/AST, MICs and conventional results
Measured: Up to 180 days
Time to achieve targeted optimized therapy
It includes both pathogen-appropriate drug selection and appropriate dosing with plasma ABX concentration achieving PK/PD targets.
Measured: Up to 180 days
Time to antibiotic switches
Measured: Up to 180 days
Number of started, stopped, added or adjusted (escalation or de-escalation) antibiotics
Measured: Up to 180 days
Time to Aantibiotic dose adjustments to achieve PK/PD targets
Measured: Up to 180 days
All-Cause mortality
At ICU
Measured: Up to 180 days
All-Cause mortality
At hospital discharge
Measured: Up to 180 days
All Cause Mortality
Measured: At day 90
All Cause Mortality
Measured: At day 180
SOFA score assessment
Evolution of organ failures by daily SOFA score assessment
Measured: Up to 28 days
Organ-failure free days (SOFA<6)
Measured: Up to day 28
Proportion of patients requiring invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: At day 7
Proportion of patients requiring invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: At day 14
Proportion of patients requiring invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: At day 28
Proportion of patients requiring invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: At day 90
Ventilator free days
Measured: At day 28
Vasopressor free days
Measured: At day 28
Vasopressor free days
Measured: At day 90
ICU length of stay
Measured: up to day 180
Hospital length of stay
Measured: up to day 180
Number of serious adverse events
As per MEDDRA classification
Measured: up to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956053
- Sponsor's protocol ID
- APHP180673
- Acronym
- IDAST
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 2 May 2025
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Optimization of Antibiotic Therapy in Pulmonary Sepsis Critically Ill Patients Through Application of Rapid Microbiological Diagnostic Technologies and Pharmacokinetic/Pharmacodynamic Modelling
- ClinicalTrials.gov ID
- NCT06956053
- Acronym / sponsor ID
- IDAST / APHP180673
- Conditions
- Pulmonary Sepsis
- Keywords
- Pulmonary sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 658 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 2 May 2025 (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.
Severe community-acquired and nosocomial pneumonia are associated with substantial morbidity and mortality. Early and appropriate antimicrobial therapy (AAT) is consistently the most effective intervention for reducing mortality. Cure is most likely when pharmacokinetic (PK) / pharmacodynamics (PD) targets associated with maximum antibiotic (ABX) activity are achieved. However, the process of optimizing antibiotic therapy for critically ill patients remains a complicated challenge.
A key issue is pathogen identification (ID) with subsequent antibiotic susceptibility testing (AST) results which allow for selection of AAT. Standard laboratory procedures typically require 2-3 days to provide ID and AST results. Optimal ABX dosing/dosing intervals depend in large part on PK properties in individual patients, and antibacterial effects on the infecting bacteria (PD). Alterations in the primary PK parameters, namely volume of distribution (Vd) and clearance (CL), are commonly observed, and are the most influential parameters in determining ABX dosing and exposure. ABX dosing/dosing intervals that do not account for these features are likely to lead to suboptimal ABX exposure and therapeutic failures. Because of 48-72-hours delays in ID/AST, initial treatment is frequently inappropriate in coverage, unnecessarily broad in spectrum, and/or suboptimal in dosing.
Methods for rapid bacterial growth, ID, AST and minimum inhibitory concentration (MIC) identification were developed and are capable of quantitative ID in 1-2 hours and major AST in 6-8 hours using clinical specimens. Rapid ID of the infecting pathogen and its individual AST could significantly impact the early selection of AAT and, combined with therapeutic drug monitoring data, could be used to calculate optimized dosing regimens that are personalized for the patient in order to achieve appropriate PK/PD targets.
Hypothesis: Application of these rapid ID/AST systems, together with prospective PK/PD monitoring of antibiotic plasma concentrations, will significantly shorten time from "sample to answer" for pathogen ID/AST, enhance personalized prescribing of antibiotics, optimize the time to targeted effective and AAT, and result in decreased treatment failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid ID/AST method | Experimental | Diagnostic Test: Rapid ID/AST method |
| Conventional microbiological methods | Active comparator | Diagnostic Test: Conventional biological methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients hospitalized in ICU
- 18 years of age or older
- With a pulmonary sepsis defined a s documented or suspected acute pulmonary infection (nosocomial and community-acquired pneumonia) and a SOFA score >2.
- Written Informed consent from the patient whenever possible or written ascent from next of kin whenever present at inclusion. When a patient would not be capable of consenting prior to randomization, his/her deferred consent will be gotten.
Key exclusion criteria (8 listed)
- COVID-19 patients
- Severe anaphylactic beta-lactam allergy
- First measurements of prescribed antibiotic concentration (TDM) not possible within 24 hr after randomization
- Pregnancy or lactation
- Any decision of limitation of care
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 |
|---|---|---|
| Rapid ID/AST method1. BioFire® Film Array® Blood Culture Identification 2 BCID2 panel, bioMérieux/BioFire Diagnostics, CE marked (FDA cleared) 2. BioFire® FilmArray® Pneumonia Panels, CE marked (FDA cleared) 3. SPECIFIC REVEAL® Rapid Antimicrobial Susceptibility test (AST) System, bioMérieux/Specific Diagnostics, CE-IVD and -IVDR marked | Diagnostic test | Rapid ID/AST method |
| Conventional biological methodsUsual care | Diagnostic test | Conventional microbiological methods |
Primary outcome
Rate of treatment failure
Time frame: Up to 10 days after inclusion
It includes treatment failure that occurred early (≤72 hours) or late (>72 hours), or at both times.
21 secondary outcomes
Time to availability of pathogen
Time frame: Up to 180 days
Time to achieve targeted optimized therapy
Time frame: Up to 180 days
Time to antibiotic switches
Time frame: Up to 180 days
Number of started, stopped, added or adjusted (escalation or de-escalation) antibiotics
Time frame: Up to 180 days
Time to Aantibiotic dose adjustments to achieve PK/PD targets
Time frame: Up to 180 days
All-Cause mortality
Time frame: Up to 180 days
All-Cause mortality
Time frame: Up to 180 days
All Cause Mortality
Time frame: At day 90
All Cause Mortality
Time frame: At day 180
SOFA score assessment
Time frame: Up to 28 days
Organ-failure free days (SOFA<6)
Time frame: Up to day 28
Proportion of patients requiring invasive mechanical ventilation
Time frame: At day 7
Proportion of patients requiring invasive mechanical ventilation
Time frame: At day 14
Proportion of patients requiring invasive mechanical ventilation
Time frame: At day 28
Proportion of patients requiring invasive mechanical ventilation
Time frame: At day 90
Ventilator free days
Time frame: At day 28
Vasopressor free days
Time frame: At day 28
Vasopressor free days
Time frame: At day 90
ICU length of stay
Time frame: up to day 180
Hospital length of stay
Time frame: up to day 180
Number of serious adverse events
Time frame: up to day 180
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 2 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid ID/AST method and Conventional biological methods in people with Pulmonary Sepsis, run by Assistance Publique - Hôpitaux de Paris.
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 4 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: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Pierre Moine, MD PhD (1 47 10 77 82 ext. +33, pierre.moine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment failure (time frame: Up to 10 days after inclusion). 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 2 May 2025.