Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Vancomycin; Amikacin; Meropenem; Ciprofloxacin; Piperacillin-tazobactam; Teicoplanin; Amoxicillin-clavulanate; Cefazolin; Pharmacokinetics

Treatments: Other: Vancomycin; Other: Teicoplanin; Other: Cefazolin; Other: Piperacillin-tazobactam; Other: Meropenem; Other: Amoxicillin-clavulanate; Other: Ciprofloxacin; Other: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT06426836

EC 2015/0529

Details and patient eligibility

About

Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).

Full description

The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients admitted to the pediatric intensive care unit or cardiac intensive care unit
• patient age : 1,8 kg-15 years
• patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)
• intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
• extracorporeal membrane oxygenation circuit

Exclusion criteria

• no catheter in place for blood sampling
• absence of parental/patient consent
• known hypersensitivity to beta-lactam antibiotics and ciprofloxacin

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 8 patient groups

Amoxicillin-clavulanate

Other group

Description:

Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Amoxicillin-clavulanate

Piperacillin-tazobactam

Other group

Description:

Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Piperacillin-tazobactam

Meropenem

Other group

Description:

Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Meropenem

Cefazolin

Other group

Description:

Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Cefazolin

Vancomycin

Other group

Description:

Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Vancomycin

Teicoplanin

Other group

Description:

Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Teicoplanin

Ciprofloxacin

Other group

Description:

Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Ciprofloxacin

Amikacin

Other group

Description:

Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling

Treatment:

Other: Amikacin