A multi-centre study to define novel individualised dosing regimens to maximise antibiotic effectiveness for treatment of pneumonia in ICU

THE SPARSE PNEUDOS STUDY : A multi-centre study to define novel individualised dosing regimens to maximise antibiotic effectiveness for treatment of pneumonia in ICU - FRENCH SPARSE PNEUDOS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003582-38-FR

Enrollment

200

Registered

2023-01-04

Start date

2023-04-06

Completion date

Unknown

Last updated

2024-12-03

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 ARROW LAB 1 g Product Name: MEROPENEM Pharmaceutical Form: Powder for solution for injection/infusion Trade Name: PIPERACILLINE/TAZOBACTAM KABI 4 g/500 mg Product Name: PIPERACI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (=18 years old) ICU patients. 2. Confirmed or suspected either community-acquired pneumonia, ventilator-associated pneumonia, 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 3. Pregnant patients or lactating mothers. 4. Has received study antibiotic for more than 72 hours during current infective episode. 5. Not able to be sampled between Days 1 – 3 of study antibiotic therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective of this study is to describe the population-level systemic (i.e., plasma) and ELF PK of important antibiotics, as well as its variability, in ICU patients with pneumonia to define optimal dosing regimens that maximise therapeutic outcomes.;Secondary Objective: 1.To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma and ELF) in ICU patients with pneumonia. 2.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-level systemic (i.e., plasma) and ELF PK of important antibiotics, as well as its variability, in ICU patients with pneumonia;Timepoint(s) of evaluation of this end point: Days 1 – 3	—

Measure

Time frame

Main Objective: The overall objective of this study is to describe the population-level systemic (i.e., plasma) and ELF PK of important antibiotics, as well as its variability, in ICU patients with pneumonia to define optimal dosing regimens that maximise therapeutic outcomes.;Secondary Objective: 1.To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma and ELF) in ICU patients with pneumonia. 2.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-level systemic (i.e., plasma) and ELF PK of important antibiotics, as well as its variability, in ICU patients with pneumonia;Timepoint(s) of evaluation of this end point: Days 1 – 3

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Secondary

Measure	Time frame
Secondary end point(s): 1. To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma and ELF) in ICU patients with pneumonia. 2. To characterise the effects of beta-lactam (benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam) exposures in ELF on lung inflammation in ICU patients with pneumonia. ;Timepoint(s) of evaluation of this end point: Days 1 – 3	—

Measure

Time frame

Secondary end point(s): 1. To describe the population PK of benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam (in plasma and ELF) in ICU patients with pneumonia. 2. To characterise the effects of beta-lactam (benzylpenicillin, ceftriaxone, meropenem and piperacillin/tazobactam) exposures in ELF on lung inflammation in ICU patients with pneumonia. ;Timepoint(s) of evaluation of this end point: Days 1 – 3

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Countries

Australia, France

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