Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-31 @ 6:18 AM
Study NCT ID:
NCT00670657
Status:
COMPLETED
Last Update Posted:
2009-03-27
First Post:
2008-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CRITIC - Treatment of Candidemia and Invasive Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058387', 'term': 'Candidemia'}, {'id': 'D058365', 'term': 'Candidiasis, Invasive'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'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': 'C068538', 'term': 'liposomal amphotericin B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-26', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success at End of Trial (EOT) - Success is defined as: The definition of success is (criteria a, b, c and d must be satisfied): a. i) Absence of all clinical signs and symptoms present at baseline and absence of any new signs and symptoms that may be', 'timeFrame': 'Through 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Efficacy at the 2nd and 4th week after the end of therapy', 'timeFrame': 'Through 4th week'}, {'measure': 'Safety of the 2 mg/kg/day regimen', 'timeFrame': 'Through 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['candidemia', 'invasive candidiasis', 'Ambisome', 'liposomal amphotericin B'], 'conditions': ['Candidemia', 'Invasive Candidiasis']}, 'descriptionModule': {'briefSummary': 'Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture', 'detailedDescription': 'Subjects will be enrolled to receive intravenously AmBisome® at 2 mg/kg/day for a maximum of 4 weeks. Treatment will be discontinued in case of failure, adverse events precluding treatment or success. In case of success AmBisome® at 2 mg/kg/day should be administered for at least 5 days after the complete resolution of all clinical findings of an active infection or for at least 8 days after the last positive blood culture or culture from a normally sterile site. It is not recommended to declare failure (and therefore change treatment) before giving at least 5 days of antifungal therapy. Failures in patients given less than 5 days of treatment should be well documented (e.g. persistent positive cultures despite catheter removal, clinical deterioration in absence of any explanation other than the fungal infection). Follow-up evaluations will be conducted at 2 and 4 weeks after the end of AmBisome® therapy. At end of treatment (time point for success or failure) patients may be shifted to oral (not intravenous) antifungals at the discretion of the local investigator, once a complete response has been achieved, if secondary prophylaxis is deemed necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted to ICU for all medical reasons that meet the inclusion criteria\n* Males or non pregnant females (women of child-bearing potential must have a negative serum or urine pregnancy test at baseline).\n* Subjects who are 14 years old or older.\n* Subjects with at least one positive blood culture isolation of a Candida spp. from a specimen or from a normally sterile site (including abdominal catheters), drawn within 96 hours prior to study entry.\n* Subjects who have clinical evidence of infection AT SOME TIME WITHIN 48 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:\n\n 1. temperature\\> 38°C on 2 occasions at least 4 hours apart or one determination greater than 38.5°C (internal, at oesophagus, tympani or bladder levels).\n 2. systolic blood pressure \\< 90, or a \\>30 mm Hg decrease in systolic BP from the subject's normal baseline.\n 3. Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida\n* Subjects or their legal representative (but the subject should sign it in any case when able to) must sign a written informed consent form. Written informed consent must be obtained before any study-related procedure is carried out.\n\nExclusion Criteria:\n\n* Subjects with a history of allergy or intolerance to AmBisome®\n* Subjects who have received systemic antifungal therapy within 15 days prior to inclusion in the study\n* Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration\n* Subjects with an absolute neutrophil count of less than 500/mm3 in the 48 hours before enrolment in the study\n* Subjects with a diagnosis of AIDS (positive HIV serology in association with either CD4 cell counts \\< 200 cells/mm3or history of an opportunistic infection /neoplasm), aplastic anemia, or Chronic Granulomatous Disease.\n* Subjects with moderate or severe liver disease defined as any one or more of the following:\n\n \\* Alkaline phosphatase, ALT, AST, or total bilirubin greater than 5 times the ULN (upper limit of normal)\n* Subjects with a severe renal impairment defined by a serum creatinine of more than 2.5 mg/dL.\n* Women who are pregnant or breastfeeding.\n* Subjects who are unlikely to survive more than 24 hours.\n* Subjects who previously participated in this study.\n* Subjects who have received within the two weeks before study entry, are receiving or likely to receive any investigational drug (unlicensed new chemical entity)."}, 'identificationModule': {'nctId': 'NCT00670657', 'acronym': 'CRITIC', 'briefTitle': 'CRITIC - Treatment of Candidemia and Invasive Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'CRITIC: Phase II Pilot Multicenter Study on Efficacy and Safety of Liposomal Amphotericin B (AmBisome®) at 2 mg/kg/Day in the Treatment of Candidemia and Invasive Candidiasis in Non-Neutropenic Patients', 'orgStudyIdInfo': {'id': 'GS-IT-131-0177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AmBisome® 2 mg/kg/day in a unique daily IV administration', 'interventionNames': ['Drug: AmBisome']}], 'interventions': [{'name': 'AmBisome', 'type': 'DRUG', 'description': 'Patients will receive 2mg/kg/day IV daily administration of AmBisome® over 30-60 minutes as a reaction to signs/symptoms and positive Candida culture', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20146', 'city': 'Milan', 'country': 'Italy', 'facility': 'Gilead Sciences Srl', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Luigi Picaro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Luigi Antonio Picaro', 'oldOrganization': 'Gilead Sciences'}}}}