Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-02-22 @ 7:29 PM
Study NCT ID:
NCT00987818
Status:
WITHDRAWN
Last Update Posted:
2015-09-02
First Post:
2009-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077740', 'term': 'Procalcitonin'}], 'ancestors': [{'id': 'D002116', 'term': 'Calcitonin'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No MEC approval', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of antibiotic therapy', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biomarkers', 'Antibiotic therapy'], 'conditions': ['Sepsis', 'Intensive Care']}, 'descriptionModule': {'briefSummary': 'The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied.\n\nProcalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the ICU\n* Age \\> 18 years\n* Antibiotic therapy for sepsis with a suspected or proven focus of infection\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnancy\n* Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)\n* Indication for prolonged systemic prophylactic antibiotic therapy\n* Severe viral or parasitic infections (hemorrhagic fever, malaria)\n* Antibiotic therapy started 48 hours before enrollment\n* Severe immunocompromised patients (AIDS with a CD4 count \\< 200cells/mm3, severe neutropenia(\\<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)\n* Patients foregoing life sustaining treatment'}, 'identificationModule': {'nctId': 'NCT00987818', 'briefTitle': 'Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU', 'orgStudyIdInfo': {'id': '630-190809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCT guided antibiotic therapy', 'interventionNames': ['Other: Procalcitonin measurement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard antibiotic therapy', 'interventionNames': ['Other: Procalcitonin measurement']}], 'interventions': [{'name': 'Procalcitonin measurement', 'type': 'OTHER', 'description': 'Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.', 'armGroupLabels': ['PCT guided antibiotic therapy', 'Standard antibiotic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800TA', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Alysis Zorggroep, Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting Vrienden van het Alysis Leerhuis', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'HJ van Leeuwen, MD PhD', 'oldOrganization': 'Alysis Zorggroep, Rijnstate Hospital'}}}}