E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Invasive candidiasis or candidemia | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 | E.1.2 | Level | PT | E.1.2 | Classification code | 10042938 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 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. | |
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. | |
E.4 | Principal 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. | |
E.5 End points |
E.5.1 | 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. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | Last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |