A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER STUDY TO COMPARE THE EFFICACY AND SAFETY OF MICAFUNGIN VERSUS AMPHOTERICIN B DEOXYCHOLATE FOR THE TREATMENT OF NEONATAL CANDIDIASIS.

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.,0 个研究点目标入组 0 人开始时间: 2013年3月18日最近更新: 2023年9月4日

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•1. INSTITUTIONAL REVIEW BOARD (IRB)-/INDEPENDENT ETHICS COMMITTEE (IEC)-APPROVED WRITTEN INFORMED CONSENT AND PRIVACY LANGUAGE AS PER NATIONAL REGULATIONS (E.G., HIPAA AUTHORIZATION FOR U.S. SITES) MUST BE OBTAINED FROM LEGALLY AUTHORIZED REPRESENTATIVE PRIOR TO ANY STUDY-RELATED PROCEDURES (INCLUDING WITHDRAWAL OF PROHIBITED MEDICATION, IF APPLICABLE).
•2. INFANT GREATER THAN 48 HOURS OF LIFE UP TO DOL 120 AT THE TIME OF CULTURE ACQUISITION.
•3. DIAGNOSIS OF INVASIVE CANDIDIASIS BY ONE OF THE FOLLOWING (SEE APPENDIX 1 FOR SITE-SPECIFIC DIAGNOSTIC CRITERIA):
•A. PROVEN CANDIDEMIA: ONE POSITIVE BLOOD CULTURE COLLECTED WITHIN 4 DAYS PRIOR TO THE FIRST DOSE OF STUDY DRUG.
•B. PROVEN CANDIDURIA: ONE POSITIVE URINE FUNGAL CULTURE OBTAINED WITHIN 4 DAYS PRIOR TO THE FIRST DOSE OF STUDY DRUG BY I/O CATHETERIZATION OR SUPRAPUBIC ASPIRATION. POSITIVE FUNGAL CULTURE MUST SHOW GREATER THAN OR EQUAL TO 10³ CFU/ML IN A SINGLE URINE CULTURE COLLECTED VIA I/O CATHETERIZATION OR GREATER THAN OR EQUAL TO 10² CFU/ML IN A SINGLE URINE CULTURE COLLECTED VIA SUPRAPUBIC ASPIRATION.
•C. PROVEN CANDIDA MENINGITIS: THE PRESENCE OF CANDIDA SPECIES IN CSF CULTURE OBTAINED WITHIN +/- 4 DAYS FROM THE FIRST DOSE OF STUDY DRUG.

•1. INFANT WITH ANY HISTORY OF A HYPERSENSITIVITY OR SEVERE VASOMOTOR REACTION TO ANY ECHINO¬CANDIN OR SYSTEMIC AMPHOTERICIN B PRODUCT.
•2. INFANT WHO HAS RECEIVED MORE THAN 48 HOURS OF SYSTEMIC ANTIFUNGAL THERAPY PRIOR TO THE FIRST DOSE OF STUDY DRUG FOR TREATMENT OF THE CURRENT CANDIDA INFECTION. CUMULATIVE DOSES MUST NOT EXCEED 2 MG/KG OF CAB. FOR SYSTEMIC ANTIFUNGAL THERAPY NOT SPECIFICALLY STATED HERE, INFANTS WITH MORE THAN 2 THERAPEUTIC DAILY DOSES WITHIN THE 48 HOURS PRIOR TO THE FIRST DOSE OF STUDY DRUG WILL NOT BE ELIGIBLE.
•3. INFANT WHO HAS A BREAKTHROUGH SYSTEMIC FUNGAL INFECTION WHILE RECEIVING AN AMPHOTERICIN B PRODUCT OR AN ECHINOCANDIN AS PROPHYLAXIS.
•NOTE: INFANTS WITH A BREAKTHROUGH FUNGAL INFECTION WHILE RECEIVING AZOLE
•PROPHYLAXIS WILL BE ELIGIBLE FOR ENROLLMENT.
•4. INFANT WHO HAS FAILED PRIOR SYSTEMIC ANTIFUNGAL THERAPY FOR THIS EPISODE OF INVASIVE CANDIDIASIS, INCLUDING RECURRENCE OF THE SAME CANDIDA INFECTION WITHIN 2 WEEKS OF COMPLETING SYSTEMIC ANTIFUNGAL THERAPY.
•5. INFANT WITH A CONCOMITANT MEDICAL CONDITION, WHOSE PARTICIPATION, IN THE OPINION OF THE INVESTIGATOR AND/OR MEDICAL ADVISOR, MAY CREATE AN UNACCEPTABLE ADDITIONAL RISK.
•6. INFANT PREVIOUSLY ENROLLED IN THIS STUDY.
•7. INFANT WHO IS CO-INFECTED WITH A NON-CANDIDA FUNGAL ORGANISM..

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