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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: Proportion of patients achieving the PK/PD target [ Time Frame: First 48 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: All cause mortality [ Time Frame: 28th day ]

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: June 29, 2016
Date Started: September 2016
Date Completion: March 2017
Last Updated: July 1, 2016
Last Verified: July 2016