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Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study (NAPPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975493
Recruitment Status : Unknown
Verified March 2018 by St George's, University of London.
Recruitment status was:  Active, not recruiting
First Posted : November 3, 2013
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
St George's, University of London

Study Description
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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.

Condition or disease
Paediatric Antimicrobial Pharmacokinetics

Study Design
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Study Type : Observational
Actual Enrollment : 428 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Study Start Date : November 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples With DNA
Plasma samples and dried blood spots to be retained for retrospective analysis.

Eligibility Criteria
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Ages Eligible for Study:   1 Minute to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975493


Locations
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United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Taunton and Somerset NHS Foundation Trust
Taunton, Somerset, United Kingdom, TA1 5DA
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX
Alder Hey Children's Hospital
Liverpool, United Kingdom, L12 2AP
Liverpool Women's Hospital
Liverpool, United Kingdom, L8 7SS
St George's Hospital
London, United Kingdom, SW17 0QT
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
St George's, University of London
Investigators
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Principal Investigator: Mike Sharland, MD St George's, University of London
More Information
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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT01975493    
Other Study ID Numbers: 13.0095
2013-002366-40 ( EudraCT Number )
13/LO/0907 ( Other Identifier: Research Ethics Committee (REC) )
First Posted: November 3, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Keywords provided by St George's, University of London:
Infectious Diseases
Paediatrics
Neonatology
Pharmacokinetics
Antimicrobials