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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002366-40 | EudraCT Number | ||
| 13/LO/0907 | Other Identifier | Research Ethics Committee (REC) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin. | Participants will be followed for the duration of enrolment, an expected average of 7 days. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mike Sharland, MD | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Cornwall Hospitals NHS Trust | Truro | Cornwall | TR1 3LJ | United Kingdom | ||
| Taunton and Somerset NHS Foundation Trust |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Plasma samples and dried blood spots to be retained for retrospective analysis.
| Taunton |
| Somerset |
| TA1 5DA |
| United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | L12 2AP | United Kingdom |
| Liverpool Women's Hospital | Liverpool | L8 7SS | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Great Ormond Street Hospital | London | WC1N 3JH | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |