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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
This is a single arm study, all enrolled participants will receive the study intervention.
The First Affiliated Hospital of USTC, Anhui Province Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Henan provincial people's hospital
Zhengzhou, Henan, China
Liaocheng people's Hospital
Liaocheng, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
...and 4 more locations
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
Time frame: From Baseline to End of Study (EOS) and Prothrombin Time (PT)
Percentage of all-cause mortality following primary treatment with isavuconazole.
Time frame: Day 42 and Day 84
Crude rate of overall response at EOT
Responses based on the investigators' assessment at EOT
Time frame: Day 42, and 84
Crude rate of success of the clinical response at EOT
Responses based on the investigators' assessment at EOT
Time frame: Day 42, and 84
Crude rate of success of the mycological response at EOT
Responses based on the investigators' assessment at EOT
Time frame: Day 42, and 84
Crude rate success of the radiological responses at EOT
Responses based on the investigators' assessment at EOT
Time frame: Day 42, and 84
Number of Participants with TEAEs related to study intervention
Time frame: Day 42, and 84
Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention
Time frame: Day 42, and 84
Number of Participants with TEAE leading to discontinuation of study intervention
Time frame: Day 42, and 84
Number of Participants with TEAE leading to deaths
Time frame: Day 42, and 84
Number of all deaths
Time frame: Day 42, and 84
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Day 42, and 84
Number of Participants with Vital Signs Abnormalities
Time frame: Day 42, and 84
Number of Participants with Abnormal Electrocardiogram (ECG)
Time frame: Day 42, and 84
Number of Participants with Abnormal Eye Examination.
Time frame: Day 42, and 84
Isavuconazole plasma concentration
Time frame: Day 3, 7, 14, and EOT visit
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