None listed
Conditions
Interventions
Group 1 Type of group
Isavuconazole (BAL4815) is administered as a water-soluble prodrug of Isavuconazonium sulfate (BAL8557). Throughout the protocol, all doses of the prodrug are expressed as the corresponding amount of active substance (isavuconazole).
A loading dose of isavuconazole will be administered during the first 48 hours followed by a maintenance dose of Day 3 and up:
• 0-24 hours: Three iV infusions of 200 mg each at intervals of approximately 8 hours
• 25-48 hours: Three IV infusions of 200 mg
A CRC load dose regimen will be administered during the first 24 hours followed by a maintenance dose from 24 hours onwards:
• 0-24 hours: 6 mg / kg infusion IV b.l.d at intervals of approximately 12 hours (followed by a placebo infusion at 6 ± 2 hours in order to maintain the cecum).
• 24-48 hours: 4 mg / kg in IV infusion b.i.d. at approximately 12 hour intervals (followed by a placebo infusion at 6 ± 2 hours in order to maintain the cecum).
• Day 3 until the EOT: Maintenance dose of
Sponsors
BASILEA PHARMACEUTICA INTERNATIONAL LTD.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:clinical, mycological and radiological response to Day 42 Measure:Overall result of the treatment Timepoints:Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:clinical, mycological and radiological response to Day 84 Measure:Overall result to the EOT and to Day 84 Timepoints:day 84 ; Outcome name:Result of culture Measure:Mycological score at Day 42, EOT and Day 84 in patients with mycologically confirmed lung disease Timepoints:day 42 and 84 ; Outcome name:Global and mycological result at Day 42. EOT and Day 84 in the subpopulations defined according to stratification variables Measure:Global and mycological result at Day 42. EOT and Day 84 in the subpopulations defined according to stratification variables Timepoints:day 42 and 84 | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Italy, Netherlands, Spain, United Kindgdom
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed