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

Septic Shock Clinical Trial

— PAACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02820987
• Other study ID #: 15/493
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2016
• Est. completion date: September 1, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: NAVELLOU Jean Christophe, MD
• Email: jcnavellou[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Septic shock

• Meropenem, piperacillin-tazobactam or cefepime started after enrollment

Exclusion Criteria:

• Pregnancy

• Central nervous system infection

• Burns

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• MEROPENEM
Administration of MEROPENEM according to a protocol of extended infusion defining dose and duration of infusion.
• PIPERACILLIN-TAZOBACTAM
Administration of PIPERACILLIN-TAZOBACTAM according to a protocol of continuous infusion defining dose and duration of infusion.
• CEFEPIME
Administration of CEFEPIME according to a protocol of continuous infusion defining dose and duration of infusion.

Locations

Country	Name	City	State
France	Chu Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All cause mortality		28th day