Burned ChildrenCEFTAZOPTIMNCT03881800
Ceftazidime in Burn Children
An observational study of Burned Children and Ceftazidime Treatment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Concentrations and effects of Ceftazidime in critically ill burn children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill burn children. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Burned Children, Ceftazidime Treatment
- What is being tested?
- titration- blood sample
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2020to 11 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Burned children requiring the administration of Ceftazidime for the treatment of a documented or suspected bacterial infection
Who may be able to join
- Patient age: > 1 month and < 18 years
- Patient weight > 3 Kg
- Patient requiring the administration of Ceftazidime for the treatment of a documented or suspected bacterial infection
Who cannot join
- Patient and parents having notified to the doctor that they refuse data recovery and additional blood sample volume
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Necker - Enfants Malades (Public Hospitals of Paris)
Paris, 75015
About this study
Official title: Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children
Concentrations and effects of Ceftazidime in critically ill burn children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill burn children.
Optimization of Ceftazidime dosing is therefore desirable for all. The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) of Ceftazidime including PK/pharmacodynamic (PD) targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of covariates on Ceftazidime PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.
It will be a prospective PK study. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were Ceftazidime concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and 100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of Ceftazidime exposure on patient outcome.
Read the detailed description
Background and aims of the study:
Recent studies have suggested a risk of under-exposure to anti-infectives in critically ill adults. This under-exposure may be associated with poor clinical outcomes as well as a delay or incomplete clinical resolution of infection; The dosing regimen of anti-infectives in critically ill children is usually based on weight (i.e. mg per Kg). However, between-subject variability is known to be substantial in children and even more so with burns and in critical illness. Ceftazidime is one of the most anti-infective agents used in this vulnerable population. Given to the expected high BSV, concentrations and effects of Ceftazidime are unpredictable and the risk of under exposure- is thus considerable. Rationalization of Ceftazidime in children is therefore desirable.
The purpose of the present study is to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of Ceftazidime including usual PK/PD targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of developmental and other factors related to critical illness and burns on Ceftazidime PK and PK/PDs are investigated in order to better explain the observed between-subject variabilities and to ultimately suggest individualized dosage regimens.
This prospective study will be conducted in a paediatric intensive care unit of Public Hospitals in Paris, France
Intervention:
Patient selection will take place in paediatric intensive care unit. The senior physician proposes the study to holders of parental authority whose child receives or will receive Ceftazidime during its follow-up or hospitalization.
The senior physician will give a briefing note to the holders of parental authority, and if the child is able to understand the information. The non-oral opposition for the retrieval and analysis of data will be collected.
No intervention or no charge will be made for this study
- Conditions
- Burned Children, Ceftazidime Treatment
- Being tested
- titration- blood sample
- Keywords
- Ceftazidime, Burned Children, Intensive care, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titration- blood sampleOther
Ceftazidime titration
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftazidime concentration
6 blood samples
Measured: Up to 28 days
Secondary outcomes (9)
Weight (kg)
Composite measure of the health condition : clinical data
Measured: Up to 28 days
Body temperature (°C)
Composite measure of the health condition : clinical data
Measured: Up to 28 days
Creatinine clearance
Composite measure of the health condition : biological data
Measured: Up to 28 days
Albumin levels
Composite measure of the health condition : biological data
Measured: Up to 28 days
PELOD-2 score (severity score)
Composite measure of the health condition : clinical data
Measured: Up to 28 days
Percentage of body surface burned
Composite measure of the health condition : clinical data
Measured: Up to 28 days
C Reactive Protein
Composite measure of the health condition : biological data
Measured: Up to 28 days
Relapse
Composite measure of the health condition
Measured: Day 28 after end of Ceftazidime administration
Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen
Measured: Day 28 after end of Ceftazidime administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start19 Feb 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burned ChildrenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Mehdi OUALHA, MD PhD, Principal investigator, Hospital Necker - Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881800
- Sponsor's protocol ID
- APHP180163
- Other IDs
- 2019-A00035-52
- Acronym
- CEFTAZOPTIM
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2019
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children
- ClinicalTrials.gov ID
- NCT03881800
- Acronym / sponsor ID
- CEFTAZOPTIM / APHP180163
- Conditions
- Burned Children, Ceftazidime Treatment
- Keywords
- Ceftazidime, Burned Children, Intensive care, Pharmacokinetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concentrations and effects of Ceftazidime in critically ill burn children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill burn children.
Optimization of Ceftazidime dosing is therefore desirable for all. The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) of Ceftazidime including PK/pharmacodynamic (PD) targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of covariates on Ceftazidime PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.
It will be a prospective PK study. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were Ceftazidime concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and 100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of Ceftazidime exposure on patient outcome.
Detailed description
Background and aims of the study:
Recent studies have suggested a risk of under-exposure to anti-infectives in critically ill adults. This under-exposure may be associated with poor clinical outcomes as well as a delay or incomplete clinical resolution of infection; The dosing regimen of anti-infectives in critically ill children is usually based on weight (i.e. mg per Kg). However, between-subject variability is known to be substantial in children and even more so with burns and in critical illness. Ceftazidime is one of the most anti-infective agents used in this vulnerable population. Given to the expected high BSV, concentrations and effects of Ceftazidime are unpredictable and the risk of under exposure- is thus considerable. Rationalization of Ceftazidime in children is therefore desirable.
The purpose of the present study is to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of Ceftazidime including usual PK/PD targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of developmental and other factors related to critical illness and burns on Ceftazidime PK and PK/PDs are investigated in order to better explain the observed between-subject variabilities and to ultimately suggest individualized dosage regimens.
This prospective study will be conducted in a paediatric intensive care unit of Public Hospitals in Paris, France
Intervention:
Patient selection will take place in paediatric intensive care unit. The senior physician proposes the study to holders of parental authority whose child receives or will receive Ceftazidime during its follow-up or hospitalization.
The senior physician will give a briefing note to the holders of parental authority, and if the child is able to understand the information. The non-oral opposition for the retrieval and analysis of data will be collected.
No intervention or no charge will be made for this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Burned children requiring the administration of Ceftazidime for the treatment of a documented or suspected bacterial infection
Key inclusion criteria (3 listed)
- Patient age: > 1 month and < 18 years
- Patient weight > 3 Kg
- Patient requiring the administration of Ceftazidime for the treatment of a documented or suspected bacterial infection
Key exclusion criteria (1 listed)
- Patient and parents having notified to the doctor that they refuse data recovery and additional blood sample volume
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| titration- blood sampleCeftazidime titration | Other | – |
Primary outcome
Ceftazidime concentration
Time frame: Up to 28 days
6 blood samples
9 secondary outcomes
Weight (kg)
Time frame: Up to 28 days
Body temperature (°C)
Time frame: Up to 28 days
Creatinine clearance
Time frame: Up to 28 days
Albumin levels
Time frame: Up to 28 days
PELOD-2 score (severity score)
Time frame: Up to 28 days
Percentage of body surface burned
Time frame: Up to 28 days
C Reactive Protein
Time frame: Up to 28 days
Relapse
Time frame: Day 28 after end of Ceftazidime administration
Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen
Time frame: Day 28 after end of Ceftazidime administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi OUALHA, MD PhD principal investigator
Hospital Necker - Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burned Children and Ceftazidime Treatment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftazidime concentration (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.