Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT01391793
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2011-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Corticosteroids for Children With Febrile Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nader.shaikh@chp.edu', 'phone': '412-692-8111', 'title': 'Nader Shaikh, MD, MPH', 'organization': "UPMC Children's Hospital of Pittsburgh"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Parents were called on days 2,3 and 4 to monitor for adverse events (AEs) after administration of study medication. If the child remained febrile by day 4, daily phone calls were made until the child was afebrile. Monthly phone calls monitored for AEs; parents were reminded to call the 24-hour study line with concerns regarding their child's health. Parents were interviewed at interim visits and at the final 6-month study contact to elicit AEs.", 'description': "Staff reviewed the child's medical record for any medical care visits since their last study contact for any adverse events. If child was seen or had any new symptoms within 2 weeks of taking study product, the symptoms were reported as adverse events. After 2 weeks of taking study product, if a child was seen for fever or urinary symptoms but not diagnosed with a urinary tract infection these symptoms were reported as an adverse event.", 'eventGroups': [{'id': 'EG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 68, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 52, 'seriousNumAtRisk': 275, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Fussiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Urinary Tract Infection (UTI) symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}], 'seriousEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Fever unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Fussy infant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Retropharyngeal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Poor weight gain in infact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Acute pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Posterior urethral values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}, {'term': 'Rash; non-specific skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NIH Toxicity Tables'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days'}], 'classes': [{'title': 'With scarring', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Without scarring', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\\<24 months, \\>=24 months).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was Intent-to-Treat (ITT). The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.'}, {'type': 'PRIMARY', 'title': 'The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days'}], 'classes': [{'title': 'With severe scarring', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Without severe scarring', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.', 'statisticalMethod': 'Test of equality - 2 Poisson parameters', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The method used is a conditional test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.'}, {'type': 'SECONDARY', 'title': 'The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.127', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '0.204', 'spread': '0.046', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.', 'statisticalMethod': 'Generalized estimating equations', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\\<24 months, \\>=24 months).'}], 'paramType': 'MEAN', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.', 'unitOfMeasure': 'proportion of participants with scarring', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized to the treatment group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'Had a Positive Urine Culture', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'comment': 'Had an outcome Dimercaptosuccinic Acid (DMSA) renal scan 5-24 months from enrollment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '144'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Urine Culture Negative or Indeterminate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'No DMSA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '57'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adjuvant Dexamethasone', 'description': 'Dexamethasone: 0.15 mg/kg/dose twice daily for 3 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Twice daily for 3 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '1-23 months', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}, {'title': '24-47 months', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '48-71 months', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Site', 'classes': [{'categories': [{'title': "Children's Hospital of Pittsburgh, Pittsburgh", 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': "Nationwide Children's Hospital, Columbus", 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': "American Family Children's Hospital, Madison", 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': "Children's National Medical Center, D.C.", 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': "Hasbro Children's Hospital, Providence", 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': "Primary Children's Hospital, Salt Lake City", 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participating clinical study sites included: Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania; Nationwide Children's Hospital,Columbus, Ohio; American Family Children's Hospital, Madison, Wisconsin; Children's National Medical Center, Washington, District of Columbia; Hasbro Children's Hospital, Providence, Rhode Island; and Primary Children's Hospital, Salt Lake City, Utah", 'unitOfMeasure': 'Participants'}, {'title': 'Maternal Education', 'classes': [{'categories': [{'title': 'Less than high school', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'High school graduate or equivalent', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'College graduate', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Health Insurance', 'classes': [{'categories': [{'title': 'Private', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Public', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'None', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Type of health insurance relates to the child's health insurance.", 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Fever', 'classes': [{'categories': [{'title': '< 48 hours', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': '>= 48 hours', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Duration of fever was calculated as the absolute difference between the date and time the participant's fever began and the date and time the participant's urine was collected. The duration was categorized as less than (\\<) 48 hours or greater than or equal to (\\>=) 48 hours.", 'unitOfMeasure': 'Participants'}, {'title': 'Ibuprofen Taken in the Past 24 hours', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Escherichia Coli Present in Urine Culture', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '546 children were randomized; 271 to Adjuvant Dexamethasone and 275 to Placebo. 3 of the 271 were found ineligible post randomization \\& were withdrawn by the PI. 71 \\& 87 participants in the respective groups had negative/indeterminate cultures. The remaining 197 \\& 188 participants had positive urine cultures \\& were the basis for the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-29', 'size': 511336, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-20T12:13', 'hasProtocol': True}, {'date': '2017-11-17', 'size': 838006, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-06-20T12:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 546}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2011-07-08', 'resultsFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-24', 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.'}, {'measure': 'The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.'}], 'secondaryOutcomes': [{'measure': 'The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists', 'timeFrame': 'The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.', 'description': 'Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal scarring', 'Dexamethasone', 'Child', 'Corticosteroids', 'Pediatric', 'Urinary tract infection', 'Escherichia Coli Urinary Tract Infection'], 'conditions': ['Acute Urinary Tract Infection', 'Urinary Tract Infection']}, 'referencesModule': {'references': [{'pmid': '34251495', 'type': 'DERIVED', 'citation': 'Shaikh N, Liu H, Kurs-Lasky M, Forster CS. Biomarkers for febrile urinary tract infection in children. Pediatr Nephrol. 2022 Jan;37(1):171-177. doi: 10.1007/s00467-021-05173-x. Epub 2021 Jul 12.'}, {'pmid': '32556960', 'type': 'DERIVED', 'citation': 'Shaikh N, Shope TR, Hoberman A, Muniz GB, Bhatnagar S, Nowalk A, Hickey RW, Michaels MG, Kearney D, Rockette HE, Charron M, Lim R, Majd M, Shalaby-Rana E, Kurs-Lasky M, Cohen DM, Wald ER, Lockhart G, Pohl HG, Martin JM. Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial. Pediatr Nephrol. 2020 Nov;35(11):2113-2120. doi: 10.1007/s00467-020-04622-3. Epub 2020 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.', 'detailedDescription': 'Because host inflammatory response is the final and most important step in the formation of renal scars, the use of anti-inflammatory agents may be the best strategy to reduce renal scarring. In animal studies, the use of corticosteroids has been shown to be effective in preventing post-pyelonephritic scarring. We will conduct a randomized, double-blind, placebo-controlled trial to determine the efficacy of 3 days of daily adjuvant dexamethasone on the incidence of renal scarring 4 to 6 months after a first febrile urinary tract infection (UTI). We hypothesize that the proportion of children with UTI who develop renal scarring will be lower among children who are treated with both dexamethasone and antibiotics as compared with children treated with antibiotics alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 2 months to 6 years\n* Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick\n* Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis\n\nExclusion Criteria:\n\n* Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;\n* Planned admission to intensive care unit;\n* Known bacteremia;\n* Previous protocol defined UTI;\n* Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);\n* Congenital/acquired immunodeficiency;\n* Bag urine collection\n* Chronic diseases that could potentially interfere with response to therapy, such as chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease), liver/kidney failure;\n* Allergy to dexamethasone\n* Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)\n* Systemic use of corticosteroids or other immunomodulating agents within 14 days of enrollment\n* History of Kawasaki disease\n* Sickle cell disease (not trait)"}, 'identificationModule': {'nctId': 'NCT01391793', 'acronym': 'STARRS', 'briefTitle': 'Corticosteroids for Children With Febrile Urinary Tract Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Corticosteroids for Children With Febrile Urinary Tract Infections', 'orgStudyIdInfo': {'id': 'R01DK087870', 'link': 'https://reporter.nih.gov/quickSearch/R01DK087870', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DK087870', 'link': 'https://reporter.nih.gov/quickSearch/R01DK087870', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Inactive medicine'], 'description': 'Twice daily for 3 days', 'armGroupLabels': ['Placebo']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Prelone', 'Orapred', 'Corticosteroid'], 'description': '0.15 mg/kg/dose twice daily for 3 days', 'armGroupLabels': ['Adjuvant dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital in Columbus", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': "American Family Children's Hospital", 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Nader Shaikh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nader Shaikh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Nader Shaikh', 'investigatorAffiliation': 'University of Pittsburgh'}}}}