Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

Pfizer

Status and phase

Completed

Phase 4

Conditions

Invasive Fungal Disease

Treatments

Drug: Isavuconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT05630976

C3791001

NCT05630976 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
body weight >40 kg at screening

Exclusion criteria

either chronic aspergillosis, aspergilloma, or ABPA
Advanced HIV infection with CD4 count < 200 or acquired immunodeficiency syndrome-defining condition
people who are unlikely to survive 5 days or participants on mechanical ventilation
severe hepatic impairment (Child-Pugh Class C)
familial short QT syndrome
Concomitant 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