Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

NCT ID: NCT06426836

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-19

Study Completion Date

2026-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Amoxicillin-clavulanate

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

Group Type OTHER

Amoxicillin-clavulanate

Intervention Type OTHER

blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care

Piperacillin-tazobactam

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

Group Type OTHER

Piperacillin-tazobactam

Intervention Type OTHER

blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.

Meropenem

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

Group Type OTHER

Meropenem

Intervention Type OTHER

blood sampling in patients receiving meropenem as part of routine clinical care.

Cefazolin

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

Group Type OTHER

Cefazolin

Intervention Type OTHER

blood sampling in patients receiving cefazolin as part of routine clinical care.

Vancomycin

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

Group Type OTHER

Vancomycin

Intervention Type OTHER

blood sampling in patients receiving vancomycin as part of routine clinical care.

Teicoplanin

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

Group Type OTHER

Teicoplanin

Intervention Type OTHER

blood sampling in patients receiving teicoplanin as part of routine clinical care.

Ciprofloxacin

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

Group Type OTHER

Ciprofloxacin

Intervention Type OTHER

blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.

Amikacin

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

Group Type OTHER

Amikacin

Intervention Type OTHER

blood sampling in patients receiving amikacin as part of routine clinical care.

Interventions

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Teicoplanin

blood sampling in patients receiving teicoplanin as part of routine clinical care.

Intervention Type OTHER

Ciprofloxacin

blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.

Intervention Type OTHER

Amikacin

blood sampling in patients receiving amikacin as part of routine clinical care.

Intervention Type OTHER

Vancomycin

blood sampling in patients receiving vancomycin as part of routine clinical care.

Intervention Type OTHER

Amoxicillin-clavulanate

blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care

Intervention Type OTHER

Piperacillin-tazobactam

blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.

Intervention Type OTHER

Meropenem

blood sampling in patients receiving meropenem as part of routine clinical care.

Intervention Type OTHER

Cefazolin

blood sampling in patients receiving cefazolin as part of routine clinical care.

Intervention Type OTHER

Other Intervention Names

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Blood sampling Blood sampling Blood sampling Blood sampling Blood sampling Blood sampling Blood sampling Blood sampling

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annick de Jaeger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Queen Fabiola Children's University Hospital

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

University Hospital

Ghent, , Belgium

Site Status RECRUITING

Universitair hospital

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Pieter De Cock, PharmD

Role: CONTACT

+32 9 332 29 69

Facility Contacts

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Biarent Dominique

Role: primary

Vens Daphne

Role: backup

Pieter De Cock

Role: primary

Debaveye Yves

Role: primary

Other Identifiers

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EC 2015/0529

Identifier Type: -

Identifier Source: org_study_id

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