The study is not restricted to any specific condition. The study population will include children (aged under 16 years) admitted to hospital and routinely prescribed one of the study penicillins according to local hospital policy for any indication (including medical or surgical prophylaxis).
Conditions
Interventions
Product Name: Amoxicillin
Pharmaceutical Form:
INN or Proposed INN: Amoxicillin
CAS Number: 26787-78-0
Current Sponsor code: TBC
Other descriptive name: Amoxicillin trihydrate
Concentration unit: mg
Sponsors
St George’s, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care. 2. Informed consent form signed by parent or legal guardian. Are the trial subjects under 18? yes Number of subjects for this age range: 0 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: 1. Any child or infant unlikely to survive 48 hours after recruitment. 2. Patient known to be pregnant. 3. Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors. 4. Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, ECMO (extracorporeal membrane oxygenation) or cardiopulmonary bypass.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle objective of this study is to improve our knowledge and understanding about how babies and children absorb and process (‘metabolise’) penicillin antibiotics at the standard doses currently in use. This will be achieved by the development of population-based statistical models that represent the pharmacological ('pharmacokinetic') profiles of the study penicillins in children and babies. These pharmacokinetic profiles describe what the body does to the drug, and this refers to the processes of drug absorption, distribution within the body, metabolism and elimination; these models can help us to identify optimum dosing regimes for different age groups. ;Secondary Objective: The secondary objectives of the NAPPA study are to investigate the feasibility of new methods for pharmacokinetic studies in children: (1) The use of 'scavenged sampling' methods in an NHS clinical setting for obtaining data to generate paediatric population pharmacokinetic models (scavenged sampling refers to the research making use of small extra quantities of blood obtained at the same time as blood tests done as part of routine clinical care, and also making use of routine clinical blood samples leftover after laboratory processing that would normally be discarded). (2) The use and validity of novel dried blood-spot-based microanalytical techniques, for detecting antibiotic levels in small volume samples from paediatric patients and neonates, compared to traditional laboratory techniques (involving high-performance liquid chromatography). ;Primary end point(s): The primary endpoints will be the pharmacokinetic parameters of drug clearance and volume of distribution for the paediatric population models of each penicillin generated in NONMEM (RTM).;Timepoint(s) of evaluation of this end point: A statistical interim analysis will occur after 12 months, with an initial NONMEM analysis of the PK data available on each NAPPA penicillin, to evaluate the extent of PK | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable to this study. ;Timepoint(s) of evaluation of this end point: Not applicable to this study. | — |
Countries
United Kingdom
Contacts
Public ContactProf. Mike Sharland
St George's University of London
Outcome results
None listed