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

Last updated: January 15, 2025
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Completed

Phase

3

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Treatment

CEFEPIME

MEROPENEM

PIPERACILLIN-TAZOBACTAM

Clinical Study ID

NCT02820987
15/493
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Septic shock

  • Meropenem, piperacillin-tazobactam or cefepime started after enrollment

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Central nervous system infection

  • Burns

Study Design

Total Participants: 119
Treatment Group(s): 3
Primary Treatment: CEFEPIME
Phase: 3
Study Start date:
September 27, 2016
Estimated Completion Date:
October 04, 2018

Study 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.

Connect with a study center

  • Chu Besancon

    Besançon, 25000
    France

    Site Not Available

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