Beta-Lactams (ceftazidime, piperacilline-tazobactam, méropénem) dosing scheme validation in septic hemodialysed patient

Beta-Lactams (ceftazidime, piperacilline-tazobactam, meropenem) dosing scheme validation in septic hemodialysed patient

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001809-14-BE

Enrollment

Registered

2015-05-08

Start date

2015-06-24

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

sepsis in patient undergoing dialysis for renal insufficiency MedDRA version: 18.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10012347 Term: Dependence on renal dialysis System Organ Class: 100000004869

Interventions

Trade Name: Meropenem hospira Product Name: Meropenem Pharmaceutical Form: Powder for concentrate for solution for infusion Trade Name: Piperacilline/Tazobactam Sandoz Product Name: Piperacilline/t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patient undergoing hemodiafiltration dialysis with chronic or acute kidney disease -filtration rate less than 10ml/min - intravenous antibiotherapy by either ceftazidim, piperacilline/tazobactam or meropenem 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: -septic shock -pregnancy -dosage higher than recommanded for meningitis, osteitis or mucoviscidosis -under 18 years old -prophylaxia antibiotics treatment -obeses treatment defined as a BMI higher than 40kg/m²

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the optimal dosing scheme of beta lactams (ceftazidim, piperacilline/tazobactam and meropenem) for sepsis treatment in patient undergoing intermittent dialysis;Secondary Objective: not applicable;Primary end point(s): to evaluate the pharmacokinetic of the ceftazidim, piperacilline/tazobactam and meropenem;Timepoint(s) of evaluation of this end point: at end of the study	—

Measure

Time frame

Main Objective: to evaluate the optimal dosing scheme of beta lactams (ceftazidim, piperacilline/tazobactam and meropenem) for sepsis treatment in patient undergoing intermittent dialysis;Secondary Objective: not applicable;Primary end point(s): to evaluate the pharmacokinetic of the ceftazidim, piperacilline/tazobactam and meropenem;Timepoint(s) of evaluation of this end point: at end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactPrevost Jessica

Hopital Erasme

jessica.prevost@erasme.ulb.ac.be003225555976

Outcome results

None listed

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