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NCT05630976
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
Conditions: Invasive Fungal Disease
Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 56
Sponsor: Pfizer
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.
Eligibility Criteria
Inclusion Criteria:proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungibody weight >40 kg at screeningExclusion Criteria:either chronic aspergillosis, aspergilloma, or ABPAAdvanced HIV infection with CD4 count < 200 or acquired immunodeficiency syndrome-defining conditionpeople who are unlikely to survive 5 days or participants on mechanical ventilationsevere hepatic impairment (Child-Pugh Class C)familial short QT syndromeConcomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or St. John's Wort in the 5 days prior to first administration of study intervention
Source: ClinicalTrials.gov (NCT05630976). StuddyBuddy aggregates publicly available trial information.