Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-30 @ 2:02 AM
Study NCT ID:
NCT07093203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'C536972', 'term': 'Torulopsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peritoneal/Plasma Penetration Ratio of Rezafungin', 'timeFrame': 'From 0 to 3 hours after rezafungin administration', 'description': 'Penetration ratio of rezafungin will be calculated as the ratio of the area under the concentration-time curve from 0 to 3 hours (AUC₀-₃h) in peritoneal fluid compared to plasma in critically ill patients undergoing abdominal surgery for suspected or proven intra-abdominal candidiasis'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration-Time Profile of Rezafungin', 'timeFrame': 'From 0 to 168 hours after the first rezafungin administration', 'description': 'Area under the concentration-time curve (AUC) of rezafungin in plasma will be calculated over three time intervals: AUC₀-₂₄h, AUC₀-₄₈h, and AUC₀-₁₆₈h to describe the evolution of plasma concentrations during treatment'}, {'measure': 'Peritoneal Concentration-Time Profile of Rezafungin', 'timeFrame': 'From 0 to 48 hours after the first rezafungin administration', 'description': 'Area under the concentration-time curve (AUC) of rezafungin in peritoneal fluid will be calculated over two time intervals: AUC₀-₂₄h and AUC₀-₄₈h to describe the evolution of peritoneal concentrations during treatment.'}, {'measure': 'Target Attainment in Peritoneal Fluid at the Time of Surgery', 'timeFrame': 'At the time of abdominal surgery (within the first 3 hours after rezafungin administration)', 'description': 'Proportion of patients achieving the pharmacodynamic target in peritoneal fluid, defined as AUC₀-₃h / MIC \\> 40, measured at the time of surgery.'}, {'measure': 'Postoperative Target Attainment in Plasma', 'timeFrame': 'From 0 to 168 hours after the first rezafungin administration', 'description': 'Proportion of patients achieving the pharmacodynamic target in plasma, defined as AUC₀-₁₆₈h / MIC \\> 40'}, {'measure': 'Factors Associated with Target Attainment in Peritoneal Fluid', 'timeFrame': 'From 0 to 48 hours after the first rezafungin administration', 'description': 'Analysis of clinical and biological covariates associated with pharmacokinetic variability and the achievement of pharmacodynamic targets in peritoneal fluid'}, {'measure': 'Association Between Pharmacodynamic Target Attainment and Day-28 In-Hospital Mortality', 'timeFrame': 'From rezafungin administration to Day 28 post-treatment', 'description': 'Comparison of Day-28 in-hospital mortality rates between patients who did and did not achieve pharmacodynamic targets in plasma and/or peritoneal fluid'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['candida', 'intra-abdominal candidiasis', 'abdominal surgery', 'pharmacokinetics', 'pharmacodynamics'], 'conditions': ['Intra-Abdominal Infection', 'Candida', 'Abdominal Surgery Patients', 'Critically Ill Intensive Care Unit Patients']}, 'descriptionModule': {'briefSummary': 'ntra-abdominal candidiasis is a serious infection common in critically ill patients, often leading to high mortality if not treated quickly. Standard antifungal treatments may be less effective due to growing resistance and poor drug penetration into the abdominal cavity. In critically ill patients, drug levels can vary widely due to factors like surgery, inflammation, fluid resuscitation, or extracorporeal support, increasing the risk of underdosing. Rezafungin is a new antifungal agent with a long half-life and broad activity against Candida species, offering potential advantages in this setting. However, there is currently no data on its concentration or effectiveness in the peritoneal fluid of patients with intra-abdominal sepsis. Its long half-life, coupled with repeated pharmacokinetic variations in critical care settings and the risk of insufficient concentrations, may hinder its use in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective PK study of critically ill adult patients with proven or suspected intra-abdominal candidiasis who are admitted to the surgical ICU at the university hospital of Nancy (France).\n\nAdult critically ill patients with suspected intra-abdominal candidiasis requiring abdominal surgery and administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery, abdominal drain for at least 2 days after the surgery.\n\nIntra-abdominal candidiasis is defined following the 2024 consensus of FUNDICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* with a suspected intra-abdominal candidiasis requiring abdominal surgery\n* and receiving the administration of rezafungin as first-line empirical antifungal treatment just before the abdominal surgery\n* and having abdominal drain for at least 2 days after the surgery\n\nExclusion Criteria:\n\n* death expected within 24h\n* decline to participate'}, 'identificationModule': {'nctId': 'NCT07093203', 'acronym': 'REAREZ', 'briefTitle': 'Rezafungin Peritoneal Diffusion for Intra-abdominal Candidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Pharmacokinetic of Rezafungin in the Plasma and the Peritoneal Fluid of Critically Ill Patients With Intra-abdominal Candidiasis Requiring Abdominal Surgery', 'orgStudyIdInfo': {'id': '2024PI230'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult critically ill patients with suspected or confirmed intra-abdominal candidiasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'country': 'France', 'contacts': [{'name': 'Viviane MARTIN, PhD', 'role': 'CONTACT', 'email': 'v.martin3@chru-nancy.fr', 'phone': '+33 3 83 15 52 85'}], 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Emmanuel NOVY, MD, PhD', 'role': 'CONTACT', 'email': 'e.novy@chru-nancy.fr', 'phone': '+33 3 83 15 74 37'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mundipharma Research GmbH & Co KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}