A (pharmacokinetic/pharmacodynamic)study about the antibiotic teicoplanin used to treat infection in neonates and childre

Conditions: Gram-positive bacterial infection: late-onset neonatal sepsis, central line-associated blood stream infection, ventilator-associated pneumonia.
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-005738-12-GB

Lead Sponsor: Alder Hey Children's NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. In-patients at Alder Hey Children's NHS Foundation Trust or Liverpool Women's NHS Foundation Trust who are either:
a. Neonates (both term and pre-term(24-36 weeks gestational age), or
b. Infants and Toddlers (aged 1 month to 24 months)or
c. Children aged 2 to 16 years old, and
Who must be receiving teicoplanin for suspected or confirmed Gram positive bacterial infection while in hospital, as part of their routine clinical care.
Are the trial subjects under 18? yes
Number of subjects for this age range: 54
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Neonate, Infant/Toddler/Child considered unlikely to survive 72 hours after recruitment (as judged by the clinical team caring for the patient)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to describe how the body handles teicoplanin at different ages during childhood. This description will take the form of a population pharmacokinetic model. ;Secondary Objective: - To describe how much teicoplanin is needed to stop bacteria growing in the lab among bacteria isolated from children that teicoplanin is used to treat <br>- To explore associations between how the body handles teicoplanin, clinical outcomes;and<br>- to estimate the amount of teicoplanin needed to stop bacteria growing in the lab.;Primary end point(s): The primary endpoint will be the population pharmacokinetic parameters of drug clearance and volume of distribution for the paediatric population models generated in Non linear mixed effect modeling.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will be the Pharmacokinetic/pharmacodynamic parameter relationships, such as Area under the curve/ Minimum Inhibitory Concentration ratio (AUC/MIC)