Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-23 @ 6:09 AM
Study NCT ID:
NCT02032732
Status:
TERMINATED
Last Update Posted:
2018-11-29
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001170', 'term': 'Arthritis, Infectious'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator resigned from institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leukocyte esterase level using a leukocyte esterase test strip', 'timeFrame': 'at the time of an intraoperative joint aspiration', 'description': 'A positive leukocyte esterase test strip will be considered an indicator of a septic joint'}], 'secondaryOutcomes': [{'measure': 'baseline leukocyte esterase level for pediatric patients using a leukocyte esterase test strip', 'timeFrame': 'at the time of intraoperative joint aspiration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Joint Infection', 'Septic Arthritis']}, 'descriptionModule': {'briefSummary': 'Pediatric joint infections are a common diagnostic dilemma encountered by treating orthopaedic surgeons. No single test is sensitive or specific enough to stand alone in determining the presence of joint infection.\n\nThe purpose of this study is to test the usefulness of a chemical test strip to detect infection in fluid that is removed from a joint (intra-articular aspiration) in pediatric patients. The test strip measures an enzyme called leukocyte esterase, which has been shown to be useful in detecting the presence of infection in fluids from other parts of the body. This study will assess the efficacy of the leukocyte esterase test as a diagnostic tool for evaluating pediatric joint infections. The hypothesis of the study is that a positive leukocyte esterase test identifies a septic joint in pediatric patients undergoing intraoperative joint aspiration.', 'detailedDescription': 'Pediatric patients requiring an intra-articular joint aspiration for suspected infection or for other reasons will have a leukocyte esterase test performed on fluid removed from the joint. A convenience sample of consecutive patients will be screened according to inclusion/exclusion criteria and enrolled in the study by informed consent. All patients who will be screened for the study will have already been identified as needing an intra-articular joint aspiration in accordance with standard of care. All patients who are enrolled in the study will have the leukocyte esterase test performed on the fluid that is aspirated. Results of the test strip will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric patients at a tertiary referral center who will receive an intra-articular aspiration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients at this facility over the age of 3 months and below the age of 18 years who receive an intra-articular aspiration\n\nExclusion Criteria:\n\n* Immunocompromised patients\n* Renal failure patients\n* Patients younger than 3 months old\n* Patients 18 years of age or older\n* Volume of aspirate is less than 1.5 mL'}, 'identificationModule': {'nctId': 'NCT02032732', 'briefTitle': 'Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Utilization of Leukocyte Esterase in the Diagnosis of Pediatric Joint Infections', 'orgStudyIdInfo': {'id': '13-106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'suspected infection', 'description': 'leukocyte esterase test on fluid removed by intra-articular aspiration for suspected infection', 'interventionNames': ['Other: leukocyte esterase test']}, {'label': 'no suspected infection', 'description': 'leukocyte esterase test on fluid removed by intra-articular aspiration for reason other than suspected infection', 'interventionNames': ['Other: leukocyte esterase test']}], 'interventions': [{'name': 'leukocyte esterase test', 'type': 'OTHER', 'description': 'leukocyte esterase test on fluid removed by intra-articular aspiration', 'armGroupLabels': ['no suspected infection', 'suspected infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': "Children's Orthopaedics, Erlanger Health System", 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}], 'overallOfficials': [{'name': 'Julie Zielinski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTCOM Chattanooga/Erlanger Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}