PNEUMONIA DOSING IN CRITICALLY ILL PATIENTS

PNEUMONIA DOSING IN CRITICALLY ILL PATIENTS A multicentre study to define novel individualised dosing regimens to maximise antibiotic effectiveness for treatment of pneumonia in ICU « French cohort of the PNEUDOS Study » - French PNEUDOS Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003511-25-FR

Enrollment

100

Registered

2021-09-27

Start date

2021-11-25

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia MedDRA version: 20.0 Level: PT Classification code 10035664 Term: Pneumonia System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: MEROPENEM 1G Product Name: MEROPENEM Pharmaceutical Form: Powder for solution for injection Trade Name: PIPERACILLINE TAZOBACTAM 4G/500MG Product Name: PIPERACILLINE TAZOBACTAM Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (=18 years old) ICU patients 2. Confirmed or suspected either CAP, VAP, aspiration pneumonia or a clinically diagnosed lung infection 3. Patient has been prescribed or is receiving one of the study drugs for the treatment of pneumonia in the ICU 4. Patient is sedated and receiving mechanical ventilation 5. Patient has arterial line and urinary catheter in situ for blood and urine samplings 6. Informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Suspected or known hypersensitivity towards beta-lactam antibiotics (pre- or post-enrolment) 2. Receiving renal replacement therapy (RRT) and/or extra-corporeal membrane oxygenation (ECMO) 3. Pregnant patients or lactating mothers 4. Has received study antibiotic for more than 48 hours during current infective episode.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma, ELF and urine) in ICU patients with pneumonia. ;Secondary Objective: 2.To design optimised dosing regimens for benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam that maximise the achievement of effective ELF exposures in ICU patients with pneumonia. 3.To characterise the effects of beta-lactam (benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam) exposures in ELF on lung inflammation in ICU patients with pneumonia. ;Primary end point(s): To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma, ELF and urine) in ICU patients with pneumonia. Pk parameters;Timepoint(s) of evaluation of this end point: Period betwween 2 injections d1-D2 D3-D5	—

Measure

Time frame

Main Objective: 1.To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma, ELF and urine) in ICU patients with pneumonia. ;Secondary Objective: 2.To design optimised dosing regimens for benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam that maximise the achievement of effective ELF exposures in ICU patients with pneumonia. 3.To characterise the effects of beta-lactam (benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam) exposures in ELF on lung inflammation in ICU patients with pneumonia. ;Primary end point(s): To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma, ELF and urine) in ICU patients with pneumonia. Pk parameters;Timepoint(s) of evaluation of this end point: Period betwween 2 injections d1-D2 D3-D5

—

Secondary

Measure	Time frame
Secondary end point(s): 2- Modelisation of PK for reacging optimzed concentrations ELFantibiotic concentration 3-To characterize antibiotic B lactam ELF and blood inflamations biomarkers;Timepoint(s) of evaluation of this end point: Period betwween 2 injections d1-D2 D3-D5	—

Countries

Australia, Belgium, France, Malaysia

Contacts

Public ContactDRCI

CHU de NIMES

drc@chu-nimes.fr33466686836

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026