Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
- Conditions
- Paediatric Antimicrobial Pharmacokinetics
- Registration Number
- NCT01975493
- Lead Sponsor
- St George's, University of London
- Brief Summary
The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. The study population will involve children and neonates who need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. In addition, NAPPA will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). This allows the sample to be stored and tested later on. NAPPA will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 428
- 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.
- Informed consent form signed by parent or legal guardian.
- Any child or infant unlikely to survive 48 hours after recruitment.
- Patient known to be pregnant.
- Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors.
- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin. Participants will be followed for the duration of enrolment, an expected average of 7 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Great Ormond Street Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, Somerset, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Royal Cornwall Hospitals NHS Trust
🇬🇧Truro, Cornwall, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom