DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: N/A. Maximum age: 15 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017