Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study (NAPPA)

March 20, 2018 updated by: St George's, University of London
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

428

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
      • Liverpool, United Kingdom, L8 7SS
        • Liverpool Women's Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospitals NHS Trust
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Amoxicillin

Group 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)
Ampicillin

Group subdivided into age categories:

Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months)
Benzylpenicillin

Group 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-amoxiclav

Group 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)
Flucloxacillin

Group 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/tazobactam

Group 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.
Time Frame: Participants will be followed for the duration of enrolment, an expected average of 7 days.
Participants will be followed for the duration of enrolment, an expected average of 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Mike Sharland, MD, St George's, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13.0095
  • 2013-002366-40 (EudraCT Number)
  • 13/LO/0907 (Other Identifier: Research Ethics Committee (REC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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