Clinical trial NCT01975493: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Official title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paediatric Antimicrobial Pharmacokinetics
Keywords: Infectious Diseases
Paediatrics
Neonatology
Pharmacokinetics
Antimicrobials
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 428
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (aged under 16 years) and infants (including both full-term and premature neonates), admitted to hospital and routinely prescribed one (or more) of the study penicillins according to local hospital policy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.
timeFrame: Participants will be followed for the duration of enrolment, an expected average of 7 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
state: Cornwall
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
state: Somerset
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: St George's, University of London
name: Mike Sharland, MD
role: PRINCIPAL_INVESTIGATOR
References: