A PHASE 3, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF MICAFUNGIN (FK463) VERSUS CASPOFUNGIN AS ANTIFUNGAL TREATMENT IN PATIENTS WITH INVASIVE CANDIDIASIS OR CANDIDEMIA

• Conditions: Invasive candidiasis or candidemia; MedDRA version: 7.0Level: PTClassification code 10042938

• Registration Number: EUCTR2004-001491-39-AT
• Lead Sponsor: Astellas Pharma US, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-03
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

1. Informed consent of the patient or legally authorized representative, and HIPAA
Authorization for U.S. sites, or equivalent privacy language as per national regulations, must be obtained prior to entry. Unconscious / incapable patients may be enrolled provided written informed consent is obtained from the legally authorized representative prior to enrollment.
2. Patients must have candidemia or invasive candidiasis, documented by at least one typical clinical sign or symptom and confirmed by fungal culture and/or histology
• For candidemia or acute invasive candidiasis, a positive culture must be
documented from a sample obtained no more than 96 hours prior to the first dose of study medication.
• For chronic invasive candidiasis, a positive culture within the last 4 weeks prior to
randomization is acceptable provided the patient has findings of endophthalmitis
or hepatosplenic lesions documented by radiographic imaging and has not received
greater than two days of prior systemic antifungal therapy, as defined in exclusion
criteria #9, within the last 7 days prior to randomization.
- For invasive candidiasis, culture results may be pending at the time of enrollment if histology/cytology reveals yeast.
- For candidemia, preliminary evidence of yeast (by staining and microscopy of
the blood culture sample) is required to enroll a patient.
- A confirmation of Candida species must be obtained within one week after enrollment.
3. Patients may be of either gender. Females of childbearing potential must have a
negative pregnancy test. A pregnancy test should be performed within 14 days prior
to the first dose of study drug.
4. Patients 18 years of age or older.
5. Patients must have sufficient venous access to permit administration of study
medication and monitoring of safety variables.
Are the trial subjects under 18? no
Number of subjects for this age range:
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. Patient is pregnant or nursing. Females of childbearing potential must avoid
becoming pregnant while receiving study drug.
2. Patients with a Child-Pugh Score > 9. For patients with no findings of ascites or encephalopathy and a total bilirubin < 2 mg/dL, the Child-Pugh score does not need to be calculated.
3. Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures only of urine specimens, sputum specimens, bronchoalveolarlavage specimens or samples from indwelling drains.
4. Patients with a history of allergy, hypersensitivity, or any serious reaction to the
echinocandin class of antifungals.
5. Patients previously enrolled into this study.
6. Patients with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical adviser, may create an unacceptable additional risk.
7. Patients with a life expectancy of less than five days.
8. Patients who have received an echinocandin within one month prior to study entry.
9. Patients who have received more than two days of prior systemic antifungal therapy for the current infection.
• Daily dosing can not exceed the following: 1 mg/kg of body weight of
amphotericin B, 5 mg/kg of a lipid amphotericin B formulation, 800 mg of
fluconazole, 400 mg of itraconazole, or 12 mg/kg of body weight of voriconazole.
• Combination antifungal therapy is not allowed.
• Patients may have received prophylaxis with azoles or systemic amphotericin B
products without time restrictions.
10. Patients with yeast or mold-like infection other than invasive candidiasis or candidemia.
11. Patients receiving cyclosporine.
12. Patients known, at time of study entry or within 72 hours post randomization, to have Candida endocarditis, Candida osteomyelitis, or Candida meningitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy and safety of two dose levels of intravenous micafungin (100 mg/day and 150 mg/day) versus intravenous caspofungin in the treatment of patients with confirmed invasive candidiasis or candidemia. ;Secondary Objective: ;Primary end point(s): The primary endpoint is overall treatment success based on the Investigator’s assessment of clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of IV Therapy.