Gram-positive bacterial infection: late-onset neonatal sepsis, central line-associated blood stream infection, ventilator-associated pneumonia.
Conditions
Interventions
Trade Name: Targocid®
Product Name: Targocid®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Teicoplanin
CAS Number: 61036-62-2
Concentration unit: mg milligr
Sponsors
Alder Hey Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: - Neonate, Infant/Toddler/Child considered unlikely to survive 72 hours after recruitment (as judged by the clinical team caring for the patient)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To explore associations between how the body handles teicoplanin, clinical outcomes;and - 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Contacts
Public ContactMrs. Gillian Vernon
Liverpool Women's NHS Foundation Trust
Outcome results
None listed