Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 3:37 PM
Study NCT ID:
NCT02294695
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Intensive Care Unit stay', 'timeFrame': 'Maximum 90 days after enrollment'}, {'measure': 'Intensive Care Unit mortality', 'timeFrame': 'Maximum 90 days after enrollment'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Maximum 90 days after enrollment'}, {'measure': 'Hospital mortality', 'timeFrame': 'Maximum 90 days after enrollment'}], 'primaryOutcomes': [{'measure': 'Procalcitonin kinetic', 'timeFrame': 'The first six days after starting empiric antibiotic treatment', 'description': 'PCT levers are measured every 8 hours in the first day after starting empiric antibiotic treatment then daily and the changes in percentage are followed form the baseline value measured right before the first exposition of the antibiotic therapy.'}], 'secondaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment score', 'timeFrame': 'The first six days after starting empiric antibiotic treatment', 'description': 'SOFA score is measured every day after starting empiric antibiotic treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Empiric antibiotic therapy'], 'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 18 years with suspected infection on admission or during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical signs of infection\n* Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician\n* Suspected site of infection has to be present and documented\n* Microbiological sample sent for staining\n* Inflammatory markers available at the start of the therapy\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion\n* Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment\n* Following cardiopulmonary resuscitation\n* End stage diseases with a "do not resuscitate" order\n* Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)\n* Post cardiac surgery patients'}, 'identificationModule': {'nctId': 'NCT02294695', 'briefTitle': 'Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Szeged University'}, 'officialTitle': 'Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours', 'orgStudyIdInfo': {'id': 'EProK study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Appropriate empiric antibiotic therapy', 'description': 'Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.'}, {'label': 'Inappropriate empiric antibiotic therapy', 'description': 'Based on the microbiological results patients were grouped post hoc into "appropriate" and "inappropriate" groups by two independent experts (intensivist, infectologist) who were blinded for PCT.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H-6725', 'city': 'Szeged', 'state': 'Csongrád megye', 'country': 'Hungary', 'facility': 'Department of Anaesthesiology and Intensive Therapy', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Domonkos Trásy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ph.D. student; Department of Anaesthesiology and Intensive Therapy', 'investigatorFullName': 'Domonkos Trásy', 'investigatorAffiliation': 'Szeged University'}}}}