Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01975493

Acronym

NAPPA

Enrollment

428

Registered

2013-11-04

Start date

2013-11-30

Completion date

2018-06-30

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric Antimicrobial Pharmacokinetics

Keywords

Infectious Diseases, Paediatrics, Neonatology, Pharmacokinetics, Antimicrobials

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

United Kingdom

Outcome results