Assessment of the optimal dosing of piperacillin-tazobactam in intensive care unit patients: extended versus continuous infusion

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021050-20-BE

Enrollment

Registered

2010-07-20

Start date

2010-08-25

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients admitted on the intensive care unit (surgical and medical surgery)

Interventions

Trade Name: Tazocin 4 g Product Name: Tazocin Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: PIPERACILLIN CAS Number: 61477-96-1 Concentration unit: g gram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery). o Starting a treatment with piperacilline/tazobactam o Signed informed consent o Hematocriet >= 21% o Available arterial line Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: o age 75 years o patient's weight 100 kg o renal insufficiency (estimated clearance < 50 ML /MIN) o haemodialysis o WBC < 1000 103 µl o estimated survival <5 days o meningitis or other proven infections of the CNS o IgE-mediated allergy to penicillins o pregnancy o patients having participated in another study <30 days before o retrospectively, marked deterioration of the renal function during the study period o retrospectively, treatment < 96 h

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the standard extended dosing regimen of piperacillin-tazobactam with continuous infusion to determine the optimal dosing in an intensive care population using pharmacokinetic/pharmacodynamic approaches;Secondary Objective: ;Primary end point(s): Pharmacokinetic study to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion	—

Measure

Time frame

Main Objective: To compare the standard extended dosing regimen of piperacillin-tazobactam with continuous infusion to determine the optimal dosing in an intensive care population using pharmacokinetic/pharmacodynamic approaches;Secondary Objective: ;Primary end point(s): Pharmacokinetic study to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026