NCT02569086

Piperacillin PK Analysis in Severe Sepsis Patients

Completed Results posted Last updated 13 November 2017

What this trial tests

trial testing Blood draw in Sepsis in 22 participants. Completed in 30 June 2016.

Timeline

1 November 2015

Primary endpoint
30 June 2016

30 June 2016

Quick facts

Lead sponsor	University of Aarhus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	22
Start date	1 November 2015
Primary completion	30 June 2016
Estimated completion	30 June 2016
Sites	1 location across Denmark

Drugs / interventions tested

• Blood draw — full drug profile →

Conditions studied

• Sepsis — all drugs for Sepsis →
• Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Sepsis or Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. Primary · Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.

The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.

Group	Value	95% CI
Piperacillin Pharmacokinetics	4

50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval. Primary · Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.

The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T\>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.

Group	Value	95% CI
Piperacillin Pharmacokinetics	15

Sponsor's own description

Antibiotic dosing in septic patients poses a challenge for clinicians due to the pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for empirical treatment, and initial appropriate dosing is crucial for reducing mortality.

The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model was be established with the dual purpose to assess current standard treatment and to simulate alternative dosing regimens and modes of administration. Time above the minimal inhibitory concentration (T\>MIC) predicted for each patient was evaluated against clinical breakpoint MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T\>MIC and 50% fT\>MIC.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Population Pharmacokinetics of Piperacillin in Sepsis Patients: Should Alternative Dosing Strategies Be Considered?
   Andersen MG, Thorsted A, Storgaard M, Kristoffersson AN, et al · · 2018 · cited 27× · PMID 29507062 · DOI 10.1128/aac.02306-17