Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT00308906
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2006-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000617', 'term': 'Aminoglycosides'}], 'ancestors': [{'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Waste blood samples will be collected in order to evaluate potential genetic mechanisms of aminoglyoside induced renal injury. Waste urine samples will be collected in order to evaluate candidate protein biomarkers of aminoglycoside induced renal injury.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-30', 'studyFirstSubmitDate': '2006-03-29', 'studyFirstSubmitQcDate': '2006-03-29', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indicators of renal injury', 'timeFrame': 'Pre and post treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infection', 'renal dysfunction', 'aminoglycoside', 'protein', 'child'], 'conditions': ['Infection', 'Renal Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aminoglycoside treated and untreated newborns, infants and children.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: (1) Hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy.\n\nExclusion Criteria: (1) Current treatment with inhaled or ophthalmic aminoglycosides (2) Prior treatment with an aminoglycoside within the last 30 days'}, 'identificationModule': {'nctId': 'NCT00308906', 'briefTitle': 'Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents', 'orgStudyIdInfo': {'id': 'Aminoglycoside Waste Specimen'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Hospitalized, untreated infants and children', 'interventionNames': ['Drug: aminoglycoside']}, {'label': '2', 'description': 'Aminoglycoside treated infants and children without renal injury', 'interventionNames': ['Drug: aminoglycoside']}, {'label': '3', 'description': 'Aminoglycoside treated infants with renal injury', 'interventionNames': ['Drug: aminoglycoside']}], 'interventions': [{'name': 'aminoglycoside', 'type': 'DRUG', 'description': 'Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Lousiville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Mary Jayne Kennedy, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Louisville', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mary Jayne Kennedy', 'investigatorAffiliation': 'Virginia Commonwealth University'}}}}