Personalized Optimization of Antibiotic Therapy in Pulmonary Sepsis Critically Ill Patients Through Application of Rapid Microbiological Diagnostic Technologies and Pharmacokinetic/Pharmacodynamic Modelling
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 25, 2025
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on improving treatment for patients with pulmonary sepsis, which is a serious condition caused by lung infections. The goal is to find out if using new, faster methods to identify the bacteria causing the infection and how they respond to antibiotics can help doctors choose the best treatment more quickly. Currently, it can take 2-3 days to get test results that show what bacteria are present and what antibiotics will work against them. This study aims to shorten that time to just a few hours, allowing for more effective and personalized antibiotic therapy right when patients need it most.
To be eligible for this trial, participants must be at least 18 years old, hospitalized in the ICU, and diagnosed with pulmonary sepsis, which may include certain types of pneumonia. Patients will need to provide consent, or their family members can give consent on their behalf if they are unable. During the trial, participants can expect close monitoring of their antibiotic treatment, with adjustments made based on rapid test results to ensure they receive the most effective care as quickly as possible. This trial could potentially lead to better outcomes for critically ill patients by minimizing treatment delays and improving the effectiveness of antibiotic therapy.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported