Trial Outcomes & Findings for Piperacillin PK Analysis in Severe Sepsis Patients (NCT NCT02569086)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.

Results posted on

2017-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Piperacillin Pharmacokinetics Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Piperacillin PK Analysis in Severe Sepsis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Piperacillin Pharmacokinetics n=22 Participants Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Body weight	76 kg n=5 Participants
estimated creatinine clearance (eCLCr)	106 mL/minute n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Piperacillin Pharmacokinetics n=22 Participants Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.	4 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Piperacillin Pharmacokinetics n=22 Participants Patients with known or suspected sepsis or severe sepsis, treated empirically with piperacillin/tazobactam 4g/0,5g (Tazocin®) every eight hour (q8h).
50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval.	15 participants

Adverse Events

Piperacillin Pharmacokinetics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kristina Öbrink-Hansen

Aarhus University Hospital, Department of infectious diseases

Phone: +45

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place