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Ceftazidime in Burn Children (CEFTAZOPTIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881800
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

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.


Condition or disease Intervention/treatment
Burned Children Ceftazidime Treatment Other: titration- blood sample

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


Intervention Details:
  • Other: titration- blood sample
    Ceftazidime titration


Primary Outcome Measures :
  1. Ceftazidime concentration [ Time Frame: Up to 28 days ]
    6 blood samples


Secondary Outcome Measures :
  1. Weight (kg) [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : clinical data

  2. Body temperature (°C) [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : clinical data

  3. Creatinine clearance [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : biological data

  4. Albumin levels [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : biological data

  5. PELOD-2 score (severity score) [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : clinical data

  6. Percentage of body surface burned [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : clinical data

  7. C Reactive Protein [ Time Frame: Up to 28 days ]
    Composite measure of the health condition : biological data

  8. Relapse [ Time Frame: Day 28 after end of Ceftazidime administration ]
    Composite measure of the health condition

  9. Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen [ Time Frame: Day 28 after end of Ceftazidime administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Burned children requiring the administration of Ceftazidime for the treatment of a documented or suspected bacterial infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881800


Contacts
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Contact: Mehdi OUALHA, MD,PhD +33171196082 mehdi.oualha@nck.aphp.fr
Contact: Laure CHOUPEAUX, master 01 44 38 17 11 laure.choupeaux@aphp.fr

Locations
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France
Hospital Necker - Enfants Malades (Public Hospitals of Paris) Recruiting
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mehdi OUALHA, MD PhD Hospital Necker - Enfants Malades
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03881800    
Other Study ID Numbers: APHP180163
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ceftazidime
Burned Children
Intensive care
Pharmacokinetic
Additional relevant MeSH terms:
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Burns
Wounds and Injuries