Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03440918
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2018-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sophie.e.katz@vumc.org', 'phone': '615-343-6190', 'title': 'Dr. Sophie Katz', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Adverse events were collected as part of the safety outcomes. Providers were able to overrule antibiotic stewardship recommendations.', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Days of Antibiotic Therapy in the First 14 Days Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11.8'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Days of antibiotic therapy a participant receives following randomization will be measured', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Duration of Broad-spectrum Antibiotic Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.8'}, {'value': '0.086', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to14 days', 'description': 'Defined as vancomycin, daptomycin, amikacin, ceftazidime, cefepime, piperacillin/tazobactam, aztreonam, carbapenems', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Patients With an Antibiotic Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 days', 'description': "Number of patients with an appropriate antibiotic escalation or de-escalation based on patient's clinical status and available supporting laboratory evidence, or lack thereof, of specific type of infection", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': 'Re-initiation of Antibiotics for a Bacterial Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Re-initiation of any antibiotic for a proven or suspected bacterial infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': 'Length of Intensive Care Unit Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 14 days', 'description': 'Hospital days spent in the intensive care unit', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': 'Length of Overall Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until hospital discharge, an average of 7 days', 'description': 'Hospital days admitted to the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': 'Ventilator Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '6.1'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 14 days', 'description': 'Days spent using invasive ventilation methods (not including supplementary oxygen via nasal cannula or Vapotherm support)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Antibiotic-associated Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 14 days', 'description': 'Antibiotic-associated complications including rash, neutropenia, thrombocytopenia, acute kidney injury \\[defined as increase in serum creatinine \\> 0.3 mg per dL or \\> 1.5-fold from baseline, or urine output \\< 0.5 mL per kg per hour for more than six hours\\], hepatotoxicity \\[defined as \\> 2-fold increase in alanine aminotransferase, ALT, or conjugated bilirubin\\], or C. difficile infection will be recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)'}, {'type': 'SECONDARY', 'title': 'Infection With a Multi-drug Resistant Organism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'Identification/growth of a multi-drug resistant organism from a sterile culture site. Multi-drug resistant organisms will be defined as methicillin-resistant S. aureus, vancomycin-resistant Enterococcus, 3rd generation cephalosporin non-susceptible Enterobacteriaceae, multi-drug resistant Pseudomonas aeruginosa \\[resistant to aminoglycosides, cephalosporins, floroquinolones and carbepenems\\], carbepenem-resistant Acinetobacter, and Candida spp obtained from otherwise sterile sites \\[i.e. blood or urine cultures\\]', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)'}, {'type': 'SECONDARY', 'title': 'Antibiotic Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'data not collected', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'data not collected', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 14 days', 'description': 'Cost of antibiotic course will be obtained from hospital billing data', 'unitOfMeasure': 'dollars', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Whose Provider Adhered to the Procalcitonin-guided Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'OG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 5 days', 'description': 'Rate of clinical provider compliance with adherence to suggested antibiotic escalation or de-escalation made by the antimicrobial stewardship team based on procalcitonin levels will be tracked', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care Antimicrobial Stewardship', 'description': 'Participants received usual care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'FG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': '528 patients in the pediatric ICU were on antibiotics \\< 1 calandar day and were assessed for eligibility during the study period, February 15, 2018 to April 11, 2019.\n\n257 were excluded and did not undergo randomization.', 'preAssignmentDetails': 'No patients enrolled in the study were excluded before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual Care audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.'}, {'id': 'BG001', 'title': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to usual care audit and feedback of antimicrobial orders, the stewardship team additionally recommended procalcitonin (PCT) testing and treatment per algorithm. PCT was be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '8.9'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '0.5', 'upperLimit': '8.3'}, {'value': '1.89', 'groupId': 'BG002', 'lowerLimit': '0.49', 'upperLimit': '8.63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Location at Enrollment', 'classes': [{'categories': [{'title': 'Medical / Surgical ICU', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Cardiac ICU', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vasopressor Support', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mechanical Ventilation', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fever at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recent surgery', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Antibiotic Indication', 'classes': [{'categories': [{'title': 'Sepsis', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Pneumonia', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Final Diagnosis', 'classes': [{'categories': [{'title': 'Pneumonia', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Aspiration pneumonia', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Tracheitis', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Viral illness', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Non-infectious etiology', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intention to treat analysis - excludes 1 patient from the procalcitonin arm who underwent cardiac transplant on day 3 after enrollment'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-27', 'size': 270067, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-24T13:41', 'hasProtocol': True}, {'date': '2019-06-04', 'size': 66540, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-24T13:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2018-02-08', 'resultsFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2018-02-19', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-21', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of Antibiotic Therapy in the First 14 Days Following Randomization', 'timeFrame': '14 days', 'description': 'Days of antibiotic therapy a participant receives following randomization will be measured'}], 'secondaryOutcomes': [{'measure': 'Duration of Broad-spectrum Antibiotic Therapy', 'timeFrame': 'up to14 days', 'description': 'Defined as vancomycin, daptomycin, amikacin, ceftazidime, cefepime, piperacillin/tazobactam, aztreonam, carbapenems'}, {'measure': 'Number of Patients With an Antibiotic Change', 'timeFrame': 'up to 14 days', 'description': "Number of patients with an appropriate antibiotic escalation or de-escalation based on patient's clinical status and available supporting laboratory evidence, or lack thereof, of specific type of infection"}, {'measure': '30-day Mortality', 'timeFrame': 'up to 30 days', 'description': 'All-cause mortality'}, {'measure': 'Re-initiation of Antibiotics for a Bacterial Infection', 'timeFrame': 'up to 30 days', 'description': 'Re-initiation of any antibiotic for a proven or suspected bacterial infection'}, {'measure': 'Length of Intensive Care Unit Stay', 'timeFrame': 'up to 14 days', 'description': 'Hospital days spent in the intensive care unit'}, {'measure': 'Length of Overall Hospital Stay', 'timeFrame': 'Until hospital discharge, an average of 7 days', 'description': 'Hospital days admitted to the hospital'}, {'measure': 'Ventilator Days', 'timeFrame': 'up to 14 days', 'description': 'Days spent using invasive ventilation methods (not including supplementary oxygen via nasal cannula or Vapotherm support)'}, {'measure': 'Number of Participants With Antibiotic-associated Complications', 'timeFrame': 'up to 14 days', 'description': 'Antibiotic-associated complications including rash, neutropenia, thrombocytopenia, acute kidney injury \\[defined as increase in serum creatinine \\> 0.3 mg per dL or \\> 1.5-fold from baseline, or urine output \\< 0.5 mL per kg per hour for more than six hours\\], hepatotoxicity \\[defined as \\> 2-fold increase in alanine aminotransferase, ALT, or conjugated bilirubin\\], or C. difficile infection will be recorded'}, {'measure': 'Infection With a Multi-drug Resistant Organism', 'timeFrame': 'up to 30 days', 'description': 'Identification/growth of a multi-drug resistant organism from a sterile culture site. Multi-drug resistant organisms will be defined as methicillin-resistant S. aureus, vancomycin-resistant Enterococcus, 3rd generation cephalosporin non-susceptible Enterobacteriaceae, multi-drug resistant Pseudomonas aeruginosa \\[resistant to aminoglycosides, cephalosporins, floroquinolones and carbepenems\\], carbepenem-resistant Acinetobacter, and Candida spp obtained from otherwise sterile sites \\[i.e. blood or urine cultures\\]'}, {'measure': 'Antibiotic Cost', 'timeFrame': 'up to 14 days', 'description': 'Cost of antibiotic course will be obtained from hospital billing data'}, {'measure': 'Number of Participants Whose Provider Adhered to the Procalcitonin-guided Algorithm', 'timeFrame': 'up to 5 days', 'description': 'Rate of clinical provider compliance with adherence to suggested antibiotic escalation or de-escalation made by the antimicrobial stewardship team based on procalcitonin levels will be tracked'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infection'], 'conditions': ['Sepsis', 'Procalcitonin', 'Antimicrobial Stewardship']}, 'referencesModule': {'references': [{'pmid': '33181782', 'type': 'DERIVED', 'citation': 'Katz SE, Crook J, Gillon J, Stanford JE, Wang L, Colby JM, Banerjee R. Use of a Procalcitonin-guided Antibiotic Treatment Algorithm in the Pediatric Intensive Care Unit. Pediatr Infect Dis J. 2021 Apr 1;40(4):333-337. doi: 10.1097/INF.0000000000002986.'}]}, 'descriptionModule': {'briefSummary': 'The timely use of antibiotics can reduce morbidity and mortality associated with bacterial infections, particularly in the intensive care unit setting (ICU). Long courses of antibiotics, however, are associated with the emergence of multi-drug resistant organisms and antibiotic-associated adverse events, such as C. difficile infections. Thus, antibiotic de-escalation is an important goal of antimicrobial stewardship programs.\n\nProcalcitonin (PCT) has been investigated as a biomarker for critically ill adult patients with bacterial infection, particularly pneumonia and sepsis. The proposed project will evaluate whether a PCT testing and treatment algorithm, implemented through daily antimicrobial stewardship audit and feedback, can promote early and safe antibiotic de-escalation in the pediatric ICU.', 'detailedDescription': "The timely use of effective antibiotics can markedly reduce the morbidity and mortality associated with bacterial infections, particularly in the intensive care unit (ICU). However, in this setting, much antibiotic use is empiric, and administered to patients with non-bacterial or non-infectious causes of inflammation that do not respond to antibiotics. This widespread empiric use of antibiotics drives the emergence of multi-drug resistant organisms and antibiotic-associated adverse events, such as C. difficile infections. De-escalation of broad-spectrum empiric antibiotics for ICU patients without proven bacterial infections can reduce unnecessary antibiotic use, slow the development of antibiotic resistance, and reduce complications associated with antibiotic therapy. Thus, antibiotic de-escalation is an important goal of antimicrobial stewardship programs. Specific tests and pathways to predict which patients have bacterial infections and those that would benefit from antibiotic therapy would accelerate de-escalation and greatly facilitate antimicrobial stewardship efforts.\n\nProcalcitonin (PCT) has been investigated as a biomarker for critically ill adult patients with bacterial infection, particularly pneumonia and sepsis. Following bacteria-induced activation of monocytes and adherence of monocytes to endothelial surfaces, procalcitonin is expressed and secreted. PCT levels have been shown to rise rapidly and remain elevated during ongoing bacterial infections, and PCT levels are more specific for bacterial infections than CRP or total white blood cell count. PCT rises approximately 4 hours after bacterial exposure, peaks between 12-24 hours, and has a half-life of 24 hours once the infectious stimulus is removed.\n\nIn many adult trials investigating PCT-guided algorithms for antibiotic cessation (refer to section 3.0), a high proportion of providers (up to 50%) chose not to follow algorithm guidance for subjects randomized to the PCT-guided group. Thus, although PCT appears to be a useful guide for safe antibiotic de-escalation in the ICU, the ideal method for implementing the test and integrating it into clinical care in order to maximize its impact in the pediatric population is unclear. Notably, none of the prior trials evaluated PCT-associated outcomes in critically ill children nor integrated PCT testing into antimicrobial stewardship activities.\n\nThe investigators propose the evaluation of a PCT testing and treatment algorithm on patient outcomes in the pediatric ICU, a setting in which PCT-guided antibiotic de-escalation has not been previously studied.\n\nThe proposed project will evaluate whether a procalcitonin (PCT) testing and treatment algorithm, implemented through daily antimicrobial stewardship audit and feedback, can promote early and safe antibiotic de-escalation in the pediatric ICU. The investigators will conduct a pragmatic, prospective randomized controlled trial comparing antimicrobial use and outcomes among children admitted to the ICU who receive either: 1) Routine laboratory testing and treatment with antimicrobial stewardship review (control), or 2) PCT testing and treatment with antimicrobial stewardship review (intervention). In both arms, baseline daily review of antimicrobial management by the stewardship team will occur. In the intervention arm, the stewardship provider also will recommend PCT testing and antibiotic modifications using a PCT-based treatment algorithm. PCT levels will be measured a total of four times in the intervention arm - on enrollment, then daily through day 3 post-randomization and on day 5 post-randomization. This research is not to determine if PCT is a good test; this has already been established and evaluated as part of the FDA approval process. This pragmatic outcomes trial is evaluating if use of the PCT, implemented together with antimicrobial stewardship program oversight, improves the quality of care the investigators can provide for children at Vanderbilt Children's Hospital. The investigators hypothesize that patients in the intervention arm will have shorter duration of antibiotic therapy and similar outcomes, as compared to patients in the control arm.\n\nSpecific Aims\n\n1. Compare antimicrobial utilization among children in the ICU who receive standard-of-care testing plus stewardship vs. PCT-based treatment plus stewardship. The investigators will compare days of antibiotic therapy in the first 14 days following randomization between the study arms. The investigators will test the hypothesis that duration of antibiotic therapy will be 2 days shorter in the group with PCT-guided management vs. the group with standard of care testing and treatment.\n2. Compare clinical outcomes and safety among children in the ICU who receive standard-of-care testing plus stewardship vs. PCT-based treatment plus stewardship. The investigators will compare mortality, length of stay, recurrence of infection, and antibiotic-associated adverse events (rash, myelosuppression, renal impairment, hepatotoxicity, C. difficile infection) between the study arms. The investigators will test the hypothesis that outcomes and safety will be comparable between the study arms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or younger\n* Prescribed or administered antibiotics in the hospital less than or equal to 24 hours prior to enrollment\n* Have parents or legal guardians who provide informed consent\n* Provide assent (if \\> 7 years of age)\n\nExclusion Criteria:\n\n* Are not prescribed antibiotics in the hospital\n* Receive intravenous antibiotics within 7 days prior to identification for study enrollment\n* Primary or secondary immune deficiency\n* History of malignancy, bone marrow transplant or solid organ transplant\n* A diagnosis of cystic fibrosis\n* Neonates \\< 34 weeks gestation\n* Patients receiving treatment for endocarditis, osteomyelitis, meningitis, mediastinitis or other invasive infection, for which long duration of antibiotics is needed\n* Do not provide informed consent/assent'}, 'identificationModule': {'nctId': 'NCT03440918', 'acronym': 'ProPICU', 'briefTitle': 'Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prospective, Randomized Controlled Trial to Evaluate the Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': '170778'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Baseline Antimicrobial Stewardship', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.', 'interventionNames': ['Other: Procalcitonin-Guided Antimicrobial Stewardship', 'Other: Baseline Antimicrobial Stewardship']}, {'type': 'EXPERIMENTAL', 'label': 'Procalcitonin-Guided Antimicrobial Stewardship', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.', 'interventionNames': ['Other: Procalcitonin-Guided Antimicrobial Stewardship']}], 'interventions': [{'name': 'Procalcitonin-Guided Antimicrobial Stewardship', 'type': 'OTHER', 'description': 'In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.', 'armGroupLabels': ['Baseline Antimicrobial Stewardship', 'Procalcitonin-Guided Antimicrobial Stewardship']}, {'name': 'Baseline Antimicrobial Stewardship', 'type': 'OTHER', 'description': 'Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.', 'armGroupLabels': ['Baseline Antimicrobial Stewardship']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Ritu Banerjee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Sophie Katz', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}