Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
NCT ID: NCT01975493
Last Updated: 2018-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
428 participants
OBSERVATIONAL
2013-11-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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)
No interventions assigned to this group
Ampicillin
Group subdivided into age categories:
Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Informed consent form signed by parent or legal guardian.
Exclusion Criteria
* 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.
1 Minute
15 Years
ALL
No
Sponsors
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St George's, University of London
OTHER
Responsible Party
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Principal Investigators
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Mike Sharland, MD
Role: PRINCIPAL_INVESTIGATOR
St George's, University of London
Locations
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Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, Somerset, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
St George's Hospital
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Related Links
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Global Research in Paediatrics (GRiP)
Other Identifiers
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2013-002366-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13/LO/0907
Identifier Type: OTHER
Identifier Source: secondary_id
13.0095
Identifier Type: -
Identifier Source: org_study_id
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