Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-04-21 @ 3:37 PM
Study NCT ID:
NCT04547556
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c.prataymerich-2@umcutrecht.nl', 'phone': '+31631118128', 'title': 'Dr Cristina Prat Aymerich', 'organization': 'UMC Utrecht'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The calculated sample size for the trial NCT04547556, which is the adult arm of the ADEQUATE trial could not be achieved and study was terminated due to poor enrolment. Outcome measures that could be calculated are provided.'}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing the informed consent through study completion (day-30 for the main study or 6 months for the extension study).', 'description': 'Standard definitions of adverse events and device related events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'deathsNumAffected': 5, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Standard of Care testing', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 3, 'seriousNumAtRisk': 93, 'deathsNumAffected': 11, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Days Alive Out of Hospital (Superiority Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care diagnostic testing'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 - Day 14', 'description': 'Days alive out of hospital (superiority endpoint), within 14 days after study enrolment', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Days alive out of hospital'}, {'type': 'PRIMARY', 'title': 'Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care diagnostic testing'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '7', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 - Day 14', 'description': 'Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of antibiotic treatment days'}, {'type': 'PRIMARY', 'title': 'Adverse Outcome (Non-inferiority Safety Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care diagnostic testing'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 - Day 30', 'description': '* For initially non-admitted patients: any admission or death\n* For initially hospitalized patients: any readmission, ICU admission \\>= 24 hours after hospitalization, or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Direct Costs and Indirect Costs Within 30 Days After Enrolment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Diagnostic intervention\n\nBioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care testing'}], 'timeFrame': 'Day 1 - Day 30', 'description': '* Cost of healthcare within 30 days after enrolment, including hospital and ICU days, utilisation of non-hospital services and cost of anti-infective and concomitant medication\n* Cost of workdays lost within 30 days, including days for childcare', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome will not be analysed since direct costs and indirect costs could not be properly collected. Cost effective algorithms might change with factors as the disease incidence changes, performance of other diagnostic tests or its combination. As these other factors are also dependent on country and vary over time, the data as collected in the trial is insufficient to reliably report on cost-effectiveness in general'}, {'type': 'SECONDARY', 'title': 'Microbiological Results Obtained as Standard of Care and With the Diagnostic Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care Diagnostic Testing'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Proportion of participants with an identified respiratory pathogen in both study groups on randomisation day samples.\n\nData refers to the number of participants so in case more than one microorganism is detected in the same sample (co-detection) or same result in more than one sample, it is still counted as one participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data collected includes: sample type (upper and lower respiratory tract samples for diagnostic intervention but also blood cultures and urinary antigen tests for standard of care if applicable), type of diagnostic test, specific results. Data is also collected regarding the time elapsed until the results were received. Results are final for this trial and later on will be compared with pediatric trial results NCT04781530.'}, {'type': 'SECONDARY', 'title': 'Empirical Antibiotics Based on Antimicrobial Agent Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care testing'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 - Day 14', 'description': 'Proportion of participants on non-first-line anti-infective regimens (as defined by local guidelines).\n\nFor this report, results are defined as non first-line if the choice includes a third or fourth generation cephalosporin or a carbapenem but analysis needs to be adjusted to baseline risk factors, comorbidities, local guidelines and time to de escalation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analysis needs to integrate data from both the adult and the pediatric protocol and to adjust to local guidelines per country as well as risk factors and comorbidities. Data collected includes: antibiotics, antivirals and antifungals recording if initial, switch or addition to ongoing therapy as well as route of administration, dosing interval and start and stop date.'}, {'type': 'SECONDARY', 'title': 'Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care testing'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 - Day 14', 'description': 'For this report is presented the number of patients where the antimicrobial was switched to narrower spectrum.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Final analysis needs to integrate data from both the adult and the pediatric protocol and to adjust to local guidelines per country as well as risk factors and comorbidities. Data collected includes: antibiotics, antivirals and antifungals recording if initial, switch or addition to ongoing therapy as well as route of administration, dosing interval and start and stop date.'}, {'type': 'SECONDARY', 'title': 'Detection of Antimicrobial Resistance (Carriage or Infection) Related to the Diagnostic Intervention Results Compared to Standard of Care and Impact on Antimicrobial Stewardship Guidelines and Prevention of Hospital Acquired Infections.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care testing'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '>7 days after randomisation', 'description': 'Proportion of hospitalised participants with detection of cephalosporin-, carbapenem- or chinolone-resistant Enterobacteriaceae on any standard of care samples \\>7 days after randomisation comparing diagnostic intervention arm and standard of care arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospitalised participants. Samples obtained as standard of care during hospital stay. Detection of multidrug resistant microorganism was recorded.'}, {'type': 'SECONDARY', 'title': 'Impact on Decisions Regarding Isolation Measures Related to Test Result.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care Testing'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 - Day 30', 'description': 'Hours in individual or cohort isolation in hospitalised participants comparing the 2 groups', 'unitOfMeasure': 'hours in isolation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Hospitalised participants. Data collected includes start and stop date of individual or cohort isolation. Isolation measures in the current cohort were related to SARS-CoV-2 infection and not to the detection of multidrug resistant bacteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of care diagnostics'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'BioFire: A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Standard of care diagnostic testing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '75'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '78'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Serbia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-18', 'size': 1341170, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-21T10:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'whyStopped': 'Difficult recruitment in the context of the pandemic.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2020-09-07', 'resultsFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days Alive Out of Hospital (Superiority Endpoint)', 'timeFrame': 'Day 1 - Day 14', 'description': 'Days alive out of hospital (superiority endpoint), within 14 days after study enrolment'}, {'measure': 'Days on Therapy (DOT) With Antibiotics (Superiority Endpoint)', 'timeFrame': 'Day 1 - Day 14', 'description': 'Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days after study enrolment'}, {'measure': 'Adverse Outcome (Non-inferiority Safety Endpoint)', 'timeFrame': 'Day 1 - Day 30', 'description': '* For initially non-admitted patients: any admission or death\n* For initially hospitalized patients: any readmission, ICU admission \\>= 24 hours after hospitalization, or death'}], 'secondaryOutcomes': [{'measure': 'Direct Costs and Indirect Costs Within 30 Days After Enrolment.', 'timeFrame': 'Day 1 - Day 30', 'description': '* Cost of healthcare within 30 days after enrolment, including hospital and ICU days, utilisation of non-hospital services and cost of anti-infective and concomitant medication\n* Cost of workdays lost within 30 days, including days for childcare'}, {'measure': 'Microbiological Results Obtained as Standard of Care and With the Diagnostic Intervention', 'timeFrame': 'Day 1', 'description': 'Proportion of participants with an identified respiratory pathogen in both study groups on randomisation day samples.\n\nData refers to the number of participants so in case more than one microorganism is detected in the same sample (co-detection) or same result in more than one sample, it is still counted as one participant.'}, {'measure': 'Empirical Antibiotics Based on Antimicrobial Agent Categories', 'timeFrame': 'Day 1 - Day 14', 'description': 'Proportion of participants on non-first-line anti-infective regimens (as defined by local guidelines).\n\nFor this report, results are defined as non first-line if the choice includes a third or fourth generation cephalosporin or a carbapenem but analysis needs to be adjusted to baseline risk factors, comorbidities, local guidelines and time to de escalation.'}, {'measure': 'Antibiotic Type Switches and De-escalation Based on Antimicrobial Agent Categories', 'timeFrame': 'Day 1 - Day 14', 'description': 'For this report is presented the number of patients where the antimicrobial was switched to narrower spectrum.'}, {'measure': 'Detection of Antimicrobial Resistance (Carriage or Infection) Related to the Diagnostic Intervention Results Compared to Standard of Care and Impact on Antimicrobial Stewardship Guidelines and Prevention of Hospital Acquired Infections.', 'timeFrame': '>7 days after randomisation', 'description': 'Proportion of hospitalised participants with detection of cephalosporin-, carbapenem- or chinolone-resistant Enterobacteriaceae on any standard of care samples \\>7 days after randomisation comparing diagnostic intervention arm and standard of care arm.'}, {'measure': 'Impact on Decisions Regarding Isolation Measures Related to Test Result.', 'timeFrame': 'Day 1 - Day 30', 'description': 'Hours in individual or cohort isolation in hospitalised participants comparing the 2 groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antimicrobial prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.', 'detailedDescription': 'Objective: To assess the impact of rapid diagnostic testing of patients with Acute Respiratory Tract Infection (ARTI) at the emergency department, on (1) hospital admission rates and (2) antibiotic prescriptions (days of treatment) and (3) the non-inferiority in terms of clinical outcome. Geographical and seasonal variation will be assessed on a real time basis including pathogens of public health interest. The impact will be stratified within age groups and risk factors in order to determine the long-term clinical, public health and economic determinants for the integration of diagnostics in a global and sustainable perspective.\n\nStudy design: Prospective, multi-center, individually randomised, controlled trial.\n\nStudy population: Adults (≥18 years old) consulting in selected participating sites with CA-ARTI.\n\nStudy Intervention: The diagnostic intervention is rapid syndromic testing with:\n\n* BioFire FilmArray Pneumonia Panel plus (PP): Sputum (and/or ETA or BAL sample)\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab\n\nMain study parameters/endpoints:\n\n* Days alive out of hospital (superiority endpoint), within 14 days\n* Days on Therapy (DOT) with antibiotics (superiority endpoint), within 14 days\n* Adverse outcome (non-inferiority safety endpoint)\n\n * For initially non-admitted patients: any admission or death within 30 days\n * For initially hospitalised patients: i) any readmission, ii) ICU admission ≥ 24 hours after hospitalisation, or iii) death within 30 days Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study involves collection of data that can be obtained from medical charts and follow up questionnaires and interviews. Respiratory samples (e.g. nasopharyngeal swab, sputum) will be obtained as standard of care and diagnostic intervention (Biofire FilmArray) will be used only for participants randomised to the intervention,Based on the results of diagnostic testing (BioFire FilmArray) antibiotics may be withheld when deemed unnecessary, or a different antibiotic class may be selected when certain bacterial pathogens are detected. The risks and benefits of management decisions, complemented with adequate training, are subject to the current investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (≥18 years old) presenting to the Emergency Room with an acute illness (present for 14 days or less) with cough, and with at least 1 other lower respiratory tract symptom or clinical sign at physical examination:\n\n * Sputum production,\n * Breathlessness,\n * Chest discomfort or chest pain,\n * Wheeze,\n * Crackles,\n * Self-reported dystermia or documented fever;\n * Documented hypoxemia (adjusting definition for chronic oxygen therapy users, method of measurement) and no alternative explanation (infection, such as sinusitis; other, such as asthma).\n\n 2\\. Managing medical team considers:\n 1. to treat patient with antibiotics and/or to hospitalize patient\n\n AND\n 2. that the rapid syndromic diagnostic test result can be awaited up to a maximum of 4 hours before the decision to discharge the patient or to initiate antibiotic therapy.\n\nExclusion Criteria:\n\n1. Development of ARTI more than 48 hours after hospital admission (hospital acquired);\n2. Patients with cystic fibrosis;\n3. Less than 14 days since the last episode of respiratory tract infection;\n4. Pregnancy (confirmed by pregnancy test) and breastfeeding;\n5. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases or patients with short life expectancy;\n6. Inability to obtain informed consent from a competent patient.\n\n Based on standard of care microbiological diagnosis and thoracic imaging (when indicated):\n7. Radiologically confirmed acute lobar pneumonia;\n8. Known or suspected Pneumocystis jirovecii pneumonia or active tuberculosis;\n9. Alternative noninfectious diagnosis that explains clinical symptoms (pulmonary embolism, alveolar hemorrhage, acute heart failure, lung cancer).'}, 'identificationModule': {'nctId': 'NCT04547556', 'acronym': 'ADEQUATE', 'briefTitle': 'ADEQUATE Advanced Diagnostics for Enhanced Quality of Antibiotic Prescription', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'ADEQUATE Advanced Diagnostics for Enhanced QUality of Antibiotic Prescription in Respiratory Tract Infections in Emergency Rooms', 'orgStudyIdInfo': {'id': 'WP4b - adults'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Diagnostic intervention', 'interventionNames': ['Diagnostic Test: BioFire']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard of care testing'}], 'interventions': [{'name': 'BioFire', 'type': 'DIAGNOSTIC_TEST', 'description': 'A molecular rapid syndromic testing platform, using the following panels:\n\n* BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)\n* BioFire FilmArray Pneumonia Panel plus (PP)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'University Hospital Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'General Hospital Kragujevac', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}], 'overallOfficials': [{'name': 'Marc Bonten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioMérieux', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sponsor Central Principal Investigator: Dr. C. Prat, MD, PhD, Microbiologist', 'investigatorFullName': 'Dr. Cristina Prat', 'investigatorAffiliation': 'UMC Utrecht'}}}}