PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock

Pharmacokinetics and Pharmacodynamic (PK/PD) of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820987

Acronym

PAACS

Enrollment

119

Registered

2016-07-01

Start date

2016-09-27

Completion date

2018-10-04

Last updated

2025-01-16

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

Conditions

Septic Shock

Keywords

Septic shock, Beta Lactams, Extended infusion, PK/PD

Brief summary

This study evaluates PK/PD of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

Detailed description

Beta Lactams are the keystones of shock septic treatment. Early phase of septic shock is a period of disturbed pharmacokinetics, with augmented renal clearance and distribution volume of hydrophilic drugs as Beta Lactams. Consequently, early phase of septic shock is a period at risk of underdosing Beta Lactam, which could increase the risk of clinical failure an mortality. Data are available concerning underdosing of MEROPENEM, PIPERACILLIN-TAZOBACTAM and CEFEPIME, when administered in bolus. No data exist concerning the achievement of a target of 100% of the whole interval above 4 time the superior breakpoint of Pseudomonas Aeruginosa according to EUCAST (European Committee on Antimicrobial Susceptibility Testing), during the 48 first hours of treatment of septic shock, when Beta Lactam are administered in extended infusion.

Interventions

DRUGMEROPENEM

Administration of MEROPENEM according to a protocol of extended infusion defining dose and duration of infusion.

DRUGPIPERACILLIN-TAZOBACTAM

Administration of PIPERACILLIN-TAZOBACTAM according to a protocol of continuous infusion defining dose and duration of infusion.

DRUGCEFEPIME

Administration of CEFEPIME according to a protocol of continuous infusion defining dose and duration of infusion.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Septic shock * Meropenem, piperacillin-tazobactam or cefepime started after enrollment

Exclusion criteria

* Pregnancy * Central nervous system infection * Burns

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients achieving the PK/PD target	First 48 hours	Proportion of patients achieving the target of 100% of 48 first hours of treatment above 4 time the upper critical breakpoint for Pseudomonas Aeruginosa

Secondary

Measure	Time frame
All cause mortality	28th day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026