Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT00509834
Status:
WITHDRAWN
Last Update Posted:
2015-06-30
First Post:
2007-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058387', 'term': 'Candidemia'}, {'id': 'C536972', 'term': 'Torulopsis'}], 'ancestors': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'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': 'C466658', 'term': 'lactoferrin (1-11), human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Patient population not available', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2007-07-31', 'studyFirstSubmitQcDate': '2007-07-31', 'lastUpdatePostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haematology, biochemistry, and microbiological evaluation Adverse event monitoring.', 'timeFrame': '28 Days'}], 'secondaryOutcomes': [{'measure': 'Test of Cure (TOC): Clinical: complete resolution of clinical signs and symptoms or resolution to a point where no further antifungal therapy is judged necessary; and Microbiological: eradication of Candida identified at baseline.', 'timeFrame': '28 Days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hLF1-11', 'Candida', 'candidaemia', 'lactoferrin'], 'conditions': ['Candidaemia']}, 'descriptionModule': {'briefSummary': 'This is a phase-I, double-blind, randomized study with hLF1-11 to study the tolerability and early efficacy of hLF1-11 compared to standard fluconazole therapy in hospitalized patients with invasive Candida infection.', 'detailedDescription': 'RATIONALE FOR THE STUDY\n\nChoice of Drug\n\nFluconazole is considered "standard care" for the treatment of Candida infections, including candidaemia in hospitalized patients.\n\nPreclinical data has demonstrated that hLF1-11 possesses potent antimycotic effects against Candida sp and, importantly, to be synergistic with fluconazole, whereby Candida strains that are fluconazole-resistant become sensitive through the addition of hLF1-11\n\nChoice of Patient Population\n\nBased on preclinical data hLF1-11 has been shown to possess potent effects on Candida albicans models in vitro and in vivo. Furthermore, candidaemia (bloodstream Candida infection) is one of the most likely settings to elicit a therapeutic response since the product is presented as an intravenous formulation\n\nAs previously mentioned, fluconazole and hLF1-11 exhibit a synergistic effect in preclinical studies, whereby the effect of fluconazole is enhanced by the addition of hLF1-11.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before admission in the study.\n* Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.\n* Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.\n* Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to fluconazole or hLF1-11.\n* Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.\n* Patients with a history of fluconazole-resistant Candida species within 12 weeks.\n* Neutropenic patients with neutrophil count below 0.5x10\\^9/L.\n* Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.\n* Patients known to have AIDS or who are HIV-positive.\n* Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).\n* Patients with suspected candida osteomyelitis, endocarditis, or meningitis.\n* Patients who have received an investigational drug within three months prior to the study.\n* Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.\n* Patients considered inappropriate by the PI for enrollment in the study, for any reason.'}, 'identificationModule': {'nctId': 'NCT00509834', 'acronym': 'SLIC', 'briefTitle': 'A Study on the Tolerability and Early Efficacy of hLF1-11 in Patients With Proven Candidaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AM-Pharma'}, 'officialTitle': 'A Phase-IIa, Double-blind, Randomized Study on the Tolerability and Early Efficacy of hLF1-11 in Hospitalized Patients With Proven Candidaemia. (SLIC: Study of Lactoferrin Peptide in Infections With Candida)', 'orgStudyIdInfo': {'id': 'AMP IC 01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hLF1-11', 'description': 'hLF1-11 0.5mg', 'interventionNames': ['Drug: hLF1-11']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo formulation is Similar to hLF1-11 iv formulation except for the active component', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'hLF1-11', 'type': 'DRUG', 'description': 'The study treatment consists of IV administration of:\n\n(A) hLF1-11 (0.5mg IV bolus daily for 14 days) + fluconazole (up to 1g IV four times daily; 14 days): Group #1, n=10; OR (B) Fluconazole (up to 1g IV four times daily; 14 days) + matching placebo for hLF1-11: Group #2, n=10', 'armGroupLabels': ['hLF1-11']}, {'name': 'hLF1-11', 'type': 'DRUG', 'otherNames': ['human lactoferrin 1-11'], 'description': '0.5mg hLF1-11 iv per day for 14 consecutive days', 'armGroupLabels': ['hLF1-11']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'UMC St. Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Professor P.E. Verweij, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AM-Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}