Status:
NOT_YET_RECRUITING
Personalized Optimization of Antibiotic Therapy in Pulmonary Sepsis Critically Ill Patients Through Application of Rapid Microbiological Diagnostic Technologies and Pharmacokinetic/Pharmacodynamic Modelling
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pulmonary Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 interve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT06956053
Start Date
May 30 2025
End Date
November 30 2028
Last Update
May 2 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.