Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT03580733
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 448}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'failure rate after the beginning of treatment', 'timeFrame': '28 days', 'description': '28-day failure rate after the beginning of treatment'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 and 90 days', 'description': '28 and 90-day mortality rate'}, {'measure': 'success rate at the end of treatment', 'timeFrame': '8 days', 'description': 'success rate at the end of treatment'}, {'measure': 'slope of ß-D-glucan concentrations', 'timeFrame': '8 days', 'description': 'slope of ß-D-glucan concentrations'}, {'measure': 'mortality', 'timeFrame': '28 days', 'description': '28- 28 day mortality for subgroup analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU', 'yeast intra abdominal infection', 'candidiasis', 'ß-D-glucan', 'caspofungin'], 'conditions': ['ICU Yeast Intra-abdominal Infection']}, 'descriptionModule': {'briefSummary': 'The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.', 'detailedDescription': 'The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Covered by national health insurance\n* Admitted to ICU after surgery for intra-abdominal infection :\n\n * With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3(1)\n * Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively.\n* With written and signed informed consent\n\nExclusion Criteria:\n\n* Allergy to caspofungin\n* Life expectancy ≤ 48h\n* Expected withdrawal of treatment\n* Radiological drainage without surgery\n* Severe hepatic impairment (Child-Pugh C score)\n* Pregnant or lactating women\n* Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)\n* Infected acute pancreatitis\n* Ascites fluid infection'}, 'identificationModule': {'nctId': 'NCT03580733', 'acronym': 'CASPER', 'briefTitle': 'Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis', 'orgStudyIdInfo': {'id': 'PI2018_843_0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'antifungal therapy', 'description': 'caspofungin', 'interventionNames': ['Drug: caspofungin antifungal therapy']}], 'interventions': [{'name': 'caspofungin antifungal therapy', 'type': 'DRUG', 'description': 'caspofungin', 'armGroupLabels': ['antifungal therapy']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Herve Dupont', 'role': 'CONTACT', 'email': 'dupont.herve@chu-amiens.fr', 'phone': '33 322 087 979'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Hervé Dupont, PD', 'role': 'CONTACT', 'email': 'dupont.herve@chu-amiens.fr', 'phone': '33 322 087 979'}, {'name': 'Hervé Dupont', 'role': 'CONTACT', 'email': 'dupont.herve@chu-amiens.fr', 'phone': '33 322 087 979'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}