Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-19 @ 3:49 PM
Study NCT ID:
NCT02941068
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2016-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D009181', 'term': 'Mycoses'}], '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'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D000077336', 'term': 'Caspofungin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2016-10-15', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'fungal infection', 'timeFrame': 'six months', 'description': 'An blood specimen and abdominal drainage fluids if available were obtained for microbiological culture at the time of the gastrointestinal perforations and intra-abdominal specimen was collected at the time of the immediately surgery. All specimens were also obtained 1st, 3rd, 5th, 7th day after perforations and thereafter at 3 days intervals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe sepsis', 'intra-abdominal perforation', 'surgical intensive care unit', 'fungal infection', 'prophylactic anti-fungal treatment'], 'conditions': ['Intra-abdominal Perforation']}, 'referencesModule': {'references': [{'pmid': '16505648', 'type': 'RESULT', 'citation': 'Montravers P, Dupont H, Gauzit R, Veber B, Auboyer C, Blin P, Hennequin C, Martin C. Candida as a risk factor for mortality in peritonitis. Crit Care Med. 2006 Mar;34(3):646-52. doi: 10.1097/01.CCM.0000201889.39443.D2.'}, {'pmid': '19172247', 'type': 'RESULT', 'citation': 'Senn L, Eggimann P, Ksontini R, Pascual A, Demartines N, Bille J, Calandra T, Marchetti O. Caspofungin for prevention of intra-abdominal candidiasis in high-risk surgical patients. Intensive Care Med. 2009 May;35(5):903-8. doi: 10.1007/s00134-009-1405-8. Epub 2009 Jan 27.'}]}, 'descriptionModule': {'briefSummary': "This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.", 'detailedDescription': 'Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥16 years\n2. the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours\n3. ICU stay of at least 5 days\n4. APACHE Ⅱ score within 24 hours of randomization of 16 or more\n5. severe sepsis\n6. written informed consent -\n\nExclusion Criteria:\n\n1. documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study;\n2. fluconazole/caspofungin allergy;\n3. pregnant of lactating woman;\n4. life expectancy of 48 hours or less. -'}, 'identificationModule': {'nctId': 'NCT02941068', 'briefTitle': 'the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing PLA General Hospital'}, 'officialTitle': 'Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU', 'orgStudyIdInfo': {'id': '2012NLY032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic group', 'description': 'Patients would received intravenous fluconazole (loading dose 800 mg, then 400 mg/day) or caspofungin (loading dose 70 mg, then 50 mg/day) if patients had organ failure or renal or liver dysfunction during the immediately surgery. The antifungal treatment would continue for 5 to 7 days.', 'interventionNames': ['Drug: fluconazole and caspofungin']}, {'type': 'NO_INTERVENTION', 'label': 'Empirical group'}], 'interventions': [{'name': 'fluconazole and caspofungin', 'type': 'DRUG', 'armGroupLabels': ['Prophylactic group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'gao tao, ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing PLA General Hospital'}, {'name': 'cao chun, ph.d', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing PLA General Hospital'}, {'name': 'shi jialiang, ph.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Gao Tao', 'investigatorAffiliation': 'Nanjing PLA General Hospital'}}}}