Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-27 @ 4:34 PM
Study NCT ID:
NCT01975493
Status:
UNKNOWN
Last Update Posted:
2018-03-21
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples and dried blood spots to be retained for retrospective analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.', 'timeFrame': 'Participants will be followed for the duration of enrolment, an expected average of 7 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infectious Diseases', 'Paediatrics', 'Neonatology', 'Pharmacokinetics', 'Antimicrobials'], 'conditions': ['Paediatric Antimicrobial Pharmacokinetics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.grip-network.org/index.php/cms/en/home', 'label': 'Global Research in Paediatrics (GRiP)'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Informed consent form signed by parent or legal guardian.\n\nExclusion Criteria:\n\n* Any child or infant unlikely to survive 48 hours after recruitment.\n* Patient known to be pregnant.\n* Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors.\n* Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass.'}, 'identificationModule': {'nctId': 'NCT01975493', 'acronym': 'NAPPA', 'briefTitle': 'Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study', 'orgStudyIdInfo': {'id': '13.0095'}, 'secondaryIdInfos': [{'id': '2013-002366-40', 'type': 'EUDRACT_NUMBER'}, {'id': '13/LO/0907', 'type': 'OTHER', 'domain': 'Research Ethics Committee (REC)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amoxicillin', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)'}, {'label': 'Ampicillin', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months)'}, {'label': 'Benzylpenicillin', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)'}, {'label': 'Co-amoxiclav', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)'}, {'label': 'Flucloxacillin', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)'}, {'label': 'Piperacillin/tazobactam', 'description': 'Group subdivided into age categories:\n\nPreterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LJ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospitals NHS Trust', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'TA1 5DA', 'city': 'Taunton', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Taunton and Somerset NHS Foundation Trust', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry and Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Alder Hey Children's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L8 7SS', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Liverpool Women's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'overallOfficials': [{'name': 'Mike Sharland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}