Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO) (PADECMO)

January 15, 2026 updated by: University Hospital, Ghent

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Amoxicillin-clavulanate
Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling
Other: Amoxicillin-clavulanate
blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
Other Names:
  • Blood sampling
Other: Piperacillin-tazobactam
Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling
Other: Piperacillin-tazobactam
blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Meropenem
Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling
Other: Meropenem
blood sampling in patients receiving meropenem as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Cefazolin
Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling
Other: Cefazolin
blood sampling in patients receiving cefazolin as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Vancomycin
Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling
Other: Vancomycin
blood sampling in patients receiving vancomycin as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Teicoplanin
Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling
Other: Teicoplanin
blood sampling in patients receiving teicoplanin as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Ciprofloxacin
Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling
Other: Ciprofloxacin
blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
Other Names:
  • Blood sampling
Other: Amikacin
Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling
Other: Amikacin
blood sampling in patients receiving amikacin as part of routine clinical care.
Other Names:
  • Blood sampling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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)
Time Frame: up to 1 month
% 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)
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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)
Time Frame: up to 1 month
% 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)
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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
Time Frame: up to 1 month
% 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)
Time Frame: July 2026
% 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)
Time Frame: July 2026
% 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics
Time Frame: up to 1 month
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a percentage of time during which the unbound concentration remains above the Minimal Inhibitory Concentration (MIC) of the micro-organism of at least 50% and a maximum concentration of 10 x MIC
up to 1 month
Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin
Time Frame: up to 1 month
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of ciprofloxacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 86
up to 1 month
Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin
Time Frame: up to 1 month
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of vancomycin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 200 to 300
up to 1 month
Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin
Time Frame: up to 1 month
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of teicoplanin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is an Area-under the concentration-Time Curve of 900
up to 1 month
Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin
Time Frame: up to 1 month
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of amikacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a peak over Minimal Inhibitory Concentration Ratio of 8 to 10, trough concentration below 5 mg/L and Area under the Concentration Time Curve/MIC>399
up to 1 month
Beta-lactam antibiotics (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)
Time Frame: up to 1 month
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in first dose 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)
Time Frame: up to 1 month
% of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose 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)
Time Frame: up to 1 month
% of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
up to 1 month
Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
Time Frame: up to 1 month
% 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 first-dose conditions
up to 1 month
Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
Time Frame: up to 1 month
% of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
up to 1 month
Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
Time Frame: up to 1 month
% of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Annick de Jaeger, MD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC 2015/0529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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