Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

NCT06426836 | Recruiting

• 1 other identifier: EC 2015/0529
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (17)

• Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism

  % of patients for whom a target of fT\>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)

  % of patients for whom a fAUC/MIC target\>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)

  % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Teicoplanin: probability of target attainment with the target being a mimimal trough concentration

  % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)

  % of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)

  % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration

  % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration

  % of patients in whom the threshold for toxicity concentration\>5 mg/L is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions

  up to 1 month

• Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)

  % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions

  July 2026

• Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)

  % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions

  July 2026

Secondary Outcomes (11)

• Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics

  up to 1 month

• Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin

  up to 1 month

• Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin

  up to 1 month

• Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin

  up to 1 month

• Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin

  up to 1 month

Study Arms (8)

Amoxicillin-clavulanate

OTHER

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

Other: Amoxicillin-clavulanate

Piperacillin-tazobactam

OTHER

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

Other: Piperacillin-tazobactam

Meropenem

OTHER

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

Other: Meropenem

Cefazolin

OTHER

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

Other: Cefazolin

Vancomycin

OTHER

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

Other: Vancomycin

Teicoplanin

OTHER

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

Other: Teicoplanin

Ciprofloxacin

OTHER

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

Other: Ciprofloxacin

Amikacin

OTHER

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

Other: Amikacin

Interventions

Amoxicillin-clavulanate OTHER

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

Also known as: Blood sampling

Amoxicillin-clavulanate

Piperacillin-tazobactam OTHER

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

Also known as: Blood sampling

Piperacillin-tazobactam

Meropenem OTHER

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

Also known as: Blood sampling

Meropenem

Cefazolin OTHER

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

Also known as: Blood sampling

Cefazolin

Vancomycin OTHER

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

Also known as: Blood sampling

Vancomycin

Teicoplanin OTHER

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

Also known as: Blood sampling

Teicoplanin

Ciprofloxacin OTHER

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

Also known as: Blood sampling

Ciprofloxacin

Amikacin OTHER

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

Also known as: Blood sampling

Amikacin

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (3)

Queen Fabiola Children's University Hospital

Brussels, Brussels Capital, 1020, Belgium

RECRUITING

University Hospital

Ghent, 9000, Belgium

RECRUITING

Universitair hospital

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Blood Specimen Collection; Piperacillin, Tazobactam Drug Combination; Meropenem; Cefazolin; Vancomycin; Teicoplanin; Ciprofloxacin; Amikacin

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Tazobactam; Penicillanic Acid; Piperacillin; Sulfones; Thienamycins; Carbapenems; Cephalosporins; Thiazines; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Lipoglycopeptides; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Kanamycin; Aminoglycosides; Glycosides

Study Officials

• Annick de Jaeger, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter De Cock, PharmD

CONTACT

+32 9 332 29 69; pieter.decock@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 23, 2024
• Study Start: August 19, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

BE (3)