At a glance
ClinicalIndex Comparison Record- ✓Proven, probable, or possible invasive fungal disease (IFD) caused by Aspergillus species, Mucorales species, or other filamentous fungi
- ✓Body weight greater than 40 kg at screening
- ✕Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA)
- ✕Advanced HIV infection with CD4 count <200 or AIDS-defining condition
- ✕Unlikely to survive 5 days or on mechanical ventilation
- ✕Severe hepatic impairment (Child-Pugh Class C)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI
In Brief
A Phase 4 clinical trial evaluating Isavuconazole for Invasive Fungal Disease. Completed, enrolled 70 participants across 14 sites.
Detailed Summary
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting. This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM). The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.
Study Details
Timeline
Interventions
This is a single arm study, all enrolled participants will receive the study intervention.