Paediatric Antimicrobial Pharmacokinetics Clinical Trial
— NAPPAOfficial title:
Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
| Verified date | March 2018 |
| Source | St George's, University of London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 428 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 15 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals Coventry and Warwickshire NHS Trust | Coventry | |
| United Kingdom | Alder Hey Children's Hospital | Liverpool | |
| United Kingdom | Liverpool Women's Hospital | Liverpool | |
| United Kingdom | Great Ormond Street Hospital | London | |
| United Kingdom | St George's Hospital | London | |
| United Kingdom | John Radcliffe Hospital | Oxford | |
| United Kingdom | Queen Alexandra Hospital | Portsmouth | |
| United Kingdom | Taunton and Somerset NHS Foundation Trust | Taunton | Somerset |
| United Kingdom | Royal Cornwall Hospitals NHS Trust | Truro | Cornwall |
| Lead Sponsor | Collaborator |
|---|---|
| St George's, University of London |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |