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Paediatric Antimicrobial Pharmacokinetics | Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

Paediatric Antimicrobial Pharmacokinetics research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Paediatric Antimicrobial Pharmacokinetics

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AmoxicillinGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

AmpicillinGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months)

BenzylpenicillinGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

Co-amoxiclavGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

FlucloxacillinGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

Piperacillin/tazobactamGroup subdivided into age categories: Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

Study Status

Active, not recruiting

Start Date: November 2013

Completed Date: June 2018

Phase:

Type: Observational

Design:

Primary Outcome: The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mike Sharland, MD

Lead Sponsor: St George's, University of London

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01975493

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