NCT02820987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2018

Completed
Last Updated

January 16, 2025

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

June 29, 2016

Last Update Submit

January 15, 2025

Conditions

Septic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving the PK/PD target

    Proportion of patients achieving the target of 100% of 48 first hours of treatment above 4 time the upper critical breakpoint for Pseudomonas Aeruginosa

    First 48 hours

Secondary Outcomes (1)

  • All cause mortality

    28th day

Study Arms (3)

MEROPENEM

ACTIVE COMPARATOR

After enrollment, patients of MEROPENEM arm will receive an initial 2g bolus of MEROPENEM and 2g infusion over 3 hours every eight hours, during 48 hours, without modification of rhythm and dose according to renal function.

Drug: MEROPENEM

PIPERACILLIN-TAZOBACTAM

ACTIVE COMPARATOR

After enrollment, patients of PIPERACILLIN - TAZOBACTAM arm will receive an initial 4g bolus of PIPERACILLIN - TAZOBACTAM and a 16g continuous infusion per day, during 48 hours, without modification of rhythm and dose according to renal function.

Drug: PIPERACILLIN-TAZOBACTAM

CEFEPIME

ACTIVE COMPARATOR

After enrollment, patients of CEFEPIME arm will receive an initial 2g bolus of CEFEPIME and a 6g continuous infusion per day, during 48 hours, without modification of rhythm and dose according to renal function.

Drug: CEFEPIME

Interventions

MEROPENEMDRUG

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

MEROPENEM
PIPERACILLIN-TAZOBACTAMDRUG

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

PIPERACILLIN-TAZOBACTAM
CEFEPIMEDRUG

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

CEFEPIME

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Central nervous system infection
  • Burns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Besancon

Besançon, 25000, France

Location

Related Publications (2)

  • Taccone FS, Laterre PF, Dugernier T, Spapen H, Delattre I, Wittebole X, De Backer D, Layeux B, Wallemacq P, Vincent JL, Jacobs F. Insufficient beta-lactam concentrations in the early phase of severe sepsis and septic shock. Crit Care. 2010;14(4):R126. doi: 10.1186/cc9091. Epub 2010 Jul 1.

    PMID: 20594297RESULT

  • Winiszewski H, Despres C, Puyraveau M, Lagoutte-Renosi J, Montange D, Besch G, Floury SP, Chaignat C, Labro G, Vettoretti L, Clairet AL, Capellier G, Vivet B, Piton G. beta-lactam dosing at the early phase of sepsis: Performance of a pragmatic protocol for target concentration achievement in a prospective cohort study. J Crit Care. 2022 Feb;67:141-146. doi: 10.1016/j.jcrc.2021.10.023. Epub 2021 Nov 9.

    PMID: 34768176DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

MeropenemPiperacillin, Tazobactam Drug CombinationCefepime

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTazobactamPenicillanic AcidPenicillinsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesDrug CombinationsPharmaceutical PreparationsCephalosporinsThiazines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

September 27, 2016

Primary Completion

October 4, 2018

Study Completion

October 4, 2018

Last Updated

January 16, 2025

Record last verified: 2018-07

Locations

FR(1)