Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Information source: St George's, University of London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Paediatric Antimicrobial Pharmacokinetics
Phase: N/A
Status: Recruiting
Sponsored by: St George's, University of London Official(s) and/or principal investigator(s): Mike Sharland, MD, Principal Investigator, Affiliation: St George's, University of London
Overall contact: Tatiana Munera Huertas, PhD, Phone: +442087255382, Email: tmunerah@sgul.ac.uk
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.
Clinical Details
Official title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Study design: Time Perspective: Prospective
Primary outcome: The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.
Eligibility
Minimum age: N/A.
Maximum age: 15 Years.
Gender(s): Both.
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.
Locations and Contacts
Tatiana Munera Huertas, PhD, Phone: +442087255382, Email: tmunerah@sgul.ac.uk
University Hospitals Coventry and Warwickshire NHS Trust, Coventry CV2 2DX, United Kingdom; Recruiting Prakash Satodia, Principal Investigator
Alder Hey Children's Hospital, Liverpool L12 2AP, United Kingdom; Recruiting Andrew Riordan, MD, Principal Investigator
Liverpool Women's Hospital, Liverpool L8 7SS, United Kingdom; Recruiting Mark Turner, PhD, Principal Investigator
Great Ormond Street Hospital, London WC1N 3JH, United Kingdom; Recruiting Nigel Klein, PhD, Principal Investigator
St George's Hospital, London SW17 0QT, United Kingdom; Recruiting Mike Sharland, MD, Principal Investigator
John Radcliffe Hospital, Oxford OX3 9DU, United Kingdom; Recruiting Mark Anthony, PhD, Principal Investigator
Queen Alexandra Hospital, Portsmouth PO6 3LY, United Kingdom; Recruiting Tim Scorrer, Principal Investigator
Royal Cornwall Hospitals NHS Trust, Truro, Cornwall TR1 3LJ, United Kingdom; Recruiting Andrew Collinson, MD, Email: Andrew.collinson@rcht.cornwall.nhs.uk
Taunton and Somerset NHS Foundation Trust, Taunton, Somerset TA1 5DA, United Kingdom; Recruiting Louise Newbury, MD, Email: Louise.Newbury@tst.nhs.uk
Additional Information
Global Research in Paediatrics (GRiP)
Starting date: November 2013
Last updated: July 21, 2015
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