A phase III, double blind, randomized study to evaluate safety and efficacy of BAL8557 versus voriconazole for primary treatment of invasive fungal disease caused by Apsergillus species or other filamentous fungi.

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Patients and / or their legally authorized representative (s). if applicable, that they have been fully informed and have voluntarily given their informed consent in writing to patients unable to write and / or read but who fully understand the information verbally provided by the investigator (or his designated representative), who have verbally granted their informed consent which has been witnessed in writing by an independent person
• Ability and willingness to comply with the protocol.
• Male and female patients> 18 years of age
• Female patients should not be breastfeeding or at risk of becoming pregnant
• Patients must have a proven or probable IFD caused by Aspergillus species or other filamentous fungi

Exclusion Criteria

• Pregnant or lactating women.
• Known history of allergy, hypersensitivity or any serious reaction to the azole antifungals or to any component of the study medication.
• Patients in whom the use of CRC is contraindicated, including cardiovascular findings.
• Patients at high risk of prolongation of the QT / QTc interval, for example with a family history of prolonged QT syndrome or another form of known arrhythmia.
• Evidence of moderate or severe hepatic or renal dysfunction
• Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long-acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine, within 5 days prior to the first administration of the study medication.
• Patients with any other invasive fungal infection other than that caused by Aspergillus species or other filamentous fungi and patients with infection by Zygomycetes or Scedosporium prolificans that are not expected to respond to treatment with voriconazole.
• Patients with chronic aspergillosis, aspergilloma or ABPA.
• Microbiological findings (eg, allergies) or other temporally related potential conditions that suggest an alternative etiology of clinical features
• Patients who have been treated for more than 4 cumulative days with a systemic antifungal therapy other than fluconazole within 7 days prior to the first administration of the study medication.
• Chronic granulomatous disease, severe combined immunodeficiency, advanced human immunodeficiency virus infection, with a CD4 count <200 or a condition defined as acquired immunodeficiency syndrome, body weight <40 kg.
• Any known or suspected condition of the patient that could jeopardize adherence to protocol requirements or preclude accurate measurement of efficacy (eg, neutropenia, when not expected to resolve, patients with endocarditis, osteomyelitis, meningitis) , uncontrolled malignant disease (palliative therapy, refractory to treatment only), with life expectancy of less than 30 days.
• Patients with a concomitant medical condition that, in the opinion of the investigator, may constitute an unacceptable additional risk to the patient´s health if they participate in the study.
• Patients previously enrolled in a phase III study with isavuconazole.
• Treatment with any investigational drug in any clinical trial within 30 days prior to the first administration of the study medication, except for non-phase III studies.
• Patients who are not likely to survive more than 5 days or patients on mechanical ventilation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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