Hospital Necker - Enfants Malades (Public Hospitals of Paris)
Paris, 75015, France
Completed
NCT Number: NCT03881800
Ceftazidime in 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.
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Conditions
Age range
1 month–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Patient and parents having notified to the doctor that they refuse data recovery and additional blood sample volume
Treatment and study plan
titration- blood sample
OtherCeftazidime titration
Primary outcomes
-
Ceftazidime concentration
Time frame: Up to 28 days
6 blood samples
Secondary outcomes
-
Weight (kg)
Time frame: Up to 28 days
Composite measure of the health condition : clinical data
-
Body temperature (°C)
Time frame: Up to 28 days
Composite measure of the health condition : clinical data
-
Creatinine clearance
Time frame: Up to 28 days
Composite measure of the health condition : biological data
-
Albumin levels
Time frame: Up to 28 days
Composite measure of the health condition : biological data
-
PELOD-2 score (severity score)
Time frame: Up to 28 days
Composite measure of the health condition : clinical data
-
Percentage of body surface burned
Time frame: Up to 28 days
Composite measure of the health condition : clinical data
-
C Reactive Protein
Time frame: Up to 28 days
Composite measure of the health condition : biological data
-
Relapse
Time frame: Day 28 after end of Ceftazidime administration
Composite measure of the health condition
-
Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen
Time frame: Day 28 after end of Ceftazidime administration
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- URC-CIC Paris Descartes Necker Cochin
Registry information
Official study title
Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children
Acronym: CEFTAZOPTIM
Important dates
- Study start
- 2020
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Mar 20, 2019
- Registry last updated
- Mar 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.