None listed
Conditions
Interventions
Isavuconazole Type of group
A loading regimen of isavuconazole will be administered at intervals of approximately 8 hours during the first 48 hours, followed by a maintenance dose from Day 3 onwards
• 0-24 hours: three IV infusions or 200 mg oral dose. • 25-48 hours: three IV infusions or 200 mg oral dose. • Day 3 to EOT: maintenance dose of 200 mg IV or oral dose once a day.
Sponsors
BASILEA PHARMACEUTICA INTERNATIONAL LTD.,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Patients who have been fully informed and have voluntarily given written informed consent or whose legally authorized representative (s) have been fully informed and have voluntarily given written informed consent. , in his case or patients unable to write and / or read but who fully understand the information verbally provided by the researcher (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 due to any of the following reasons: - they have been postmenopausal for at least 1 year - they have undergone a hysterectomy and / or bilateral ovariectomy - if they are potentially fertile , who obtained a negative result in the pregnancy test of human chorionic gonadotropin (hcg) in urine or serum in the selection and who are using a highly effective method of birth control throughout the study. Responsible sexual abstinence throughout the study is as acceptable as a highly effective method of birth control for the purposes of this study. • Patients included in one of the following 2 subgroups: Patients with proven or probable invasive aspergillosis and patients with proven IFD caused by uncommon molds, yeasts or dimorphic fungi
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women. • Known history of allergy, hypersensitivity or any serious reaction to azole antifungals or to any component of the study medication. • Patients with a high risk of prolongation of the QT / QTc interval, for example with a family history of prolonged QT syndrome or another form of known pro-arrhythmia. • Evidence of severe hepatic dysfunction with any of the following abnormal laboratory parameters at the screening visit: - Total bilirubin x 3 times the upper limit of normal (ULN) - Alanine transaminase (ALT) or aspartate transaminase (ASI) x 5 times the ULN • Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids. long-acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine, in the 5 days prior to the first administration of the study medication. • Patients-with-aspergillosiscronicaraspergiloma-o-ABRA • Microbiological findings (eg, virological) or other potentially temporally related conditions that suggest an alternative etiology of clinical features • Advanced infection by human immunodeficiency virus with a CD4 count <200 or condition defined as acquired immunodeficiency syndrome. • Any known or suspected patient condition that may jeopardize adherence to protocol requirements or Prevent 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. (NB patients may be transferred from study WSA-CS-004 if mycology identifies zygomycetes, which is not expected to be susceptible to voriconazole). • Treatment with any investigational drug in any clinical trial within the • 30 days prior to the first administration of the medication under study, except for non-blind studies in phase III. • Patients who are not likely to survive more than 5 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Mycological and radiological clinical response evaluated at Day 42 and EOT per subgroup (for example, type of pathogen). Measure:Overall result of treatment Timepoints:Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical response criteria Success: Resolution of all attributable signs and symptoms Clinically significant improvement of all attributable signs and symptoms Failure: No significant improvement in attributable signs and symptoms and / or impairment and unavailable outcomes / non-evaluable patients Measure:Clinical response by subgroup at Day 42 and 84, EOT and FU Timepoints:Day 42 and 84, EOT and FU ; Outcome name:Complete mycological evaluation of the patients IFD status according to the best local practices and using local laboratories. Outside of these mandatory time points, mycological evaluations will only be performed if clinically indicated and / or in accordance with standard clinical management for the patient-specific IFD and the anatomical site involved. Measure:Mycological response by group of pathogens at Day 42 and 84, EOT and FU Timepoints:Day 42 and 84, EOT and FU ; Outcome name:Global response investigator evaluation for patients who discontinued study medication before Day 42 for some reason other than an unsatisfactory outcome (eg, unsatisfactory outcome, intolerable adverse event). Measure:Survival status by subgroup on Day 42 and 84, and FU Timepoints:Day 42 and 84, and FU | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Egypt, France, Germany, India, Israel, Mexico, Russian Federation, South Africa, Spain, United Kindgdom, United States
Contacts
Public ContactGabriela Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed