EUCTR2006-003951-18-ITActive, not recruitingNot Applicable
A PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BAL8557 VERSUS A CASPOFUNGIN FOLLOWED BY VORICONAZOLE REGIMEN IN THE TREATMENT OF CANDIDEMIA AND OTHER INVASIVE CANDIDA INFECTIONS
ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.0 sites526 target enrollmentStarted: April 12, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 526
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients and/or legally authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent OR patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person. 2. Ability and willingness to comply with the protocol 3. Male and female patients aged `?¥ 18 years 4. Female patients must be non lactating and at no risk of pregnancy for one of the following reasons - Postmenopausal for at least 1 year - Post hysterectomy and/or post-bilateral ovariectomy - If of childbearing potential, having a negative serum or urine human chorionic gonadotrophin (hCG) pregnancy test at screening and be using a highly effective method of birth control throughout the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study. 5. Patients (neutropenic and non-neutropenic) must have a positive blood or tissue (from at least one otherwise sterile internal organ) culture for candidemia or other invasive Candida infection from a sample obtained within 96 hours prior to randomization, accompanied by related clinical signs and symptoms or histological or cytological changes. Final culture results may still be pending at randomization. 6. Presence of fever (on one occasion > 38°C) or hypotension or appropriate local signs within 96 hours prior to first dose of study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Women who are pregnant or breastfeeding 2. Known history of allergy, hypersensitivity, or any serious reaction to any of the azole or echinocandin class of antifungals or to any component of the study medication. 3. Patients for whom CAS or VRC is contra-indicated. 4. Patients at high risk for QT/QTc prolongation, such as a family history of long QT syndrome or other known pro-arrhythmic conditions. 5. Evidence of moderate to severe hepatic or renal dysfunction (Child-Pugh score > 6) with any of the following abnormal laboratory parameters at screening: - Total bilirubin `?¥ 3 x upper limit of normal (ULN) - Alanine transaminase or aspartate transaminase `?¥ 5 x ULN - Calculated creatinine clearance < 10 mL/minute. 6. Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine in the 5 days prior to first administration of study medication. 7. Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens. 8. Patients with candidemia who failed a previous antifungal therapy for the same infection. 9. Patients with any invasive fungal infection other than candida spp., e.g., cryptococcosis, mould infection or endemic fungal infection. 10. Microbiological findings (e.g. bacterial infection) or other potential conditions that are temporally related and suggest an alternative etiology of the clinical features. 11. Patients who have received systemic antifungal therapy (i.e. a cumulative dose greater than any of the following: 1 mg/kg amphotericin B; 3 mg/kg liposomal AMB; 800 mg fluconazole; 12 mg/kg VRC; 400 mg itraconazole, 70 mg CAS, 150 mg micafungin, 200 mg anidulafungin), within 96 hours prior to the first administration of study medication. 12. Severe prolonged immunosuppression (e.g. chronic granulomatous disease, severe combined immunodeficiency, advanced human immunodeficiency virus infection with CD4 count < 200 or acquired immunodeficiency syndrome defining condition, severe graft versus host disease [grade III IV associated with e.g., failure of initial treatment, increased liver enzymes or hypoalbuminaemia]), or any other concomitant medical condition that may impede the accurate assessment of efficacy of study drug treatment. 13. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements such as neutropenia not expected to resolve, patients with endocarditis, osteomyelitis, meningitis, uncontrolled malignancy with life expectancy of < 30 days. 14. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study. 15. Patients previously enrolled in this study. 16. Treatment with any investigational drug in blinded phase III trials or any phase I and phase II trials within 30 days prior to the first administration of study medication.
Investigators
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