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Post Marketing Surveillance (PMS) Study of Cresemba in Korea.

CompletedN/A

Sponsor: Pfizer

Conditions: Aspergillosis, Mucormycosis

Interventions: Isauvuconazole group

Countries: South Korea

The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS).

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

* Patients aged 19 years or older
* Patients with proven or suspected diagnosis of invasive Aspergillosis or invasive Mucormycosis.
* Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:

* Patients with known hypersensitivity to the active substance of Isavuconazole or to any of the excipients.
* Patients are ineligible as determined by the investigator, such as those with familial short QT syndrome.
* Patients administrating ketoconazole, high-dose ritonavir (\>200 mg every 12 hours) or strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, phenytoin) that cannot be discontinued before administration of Cresemba.

Locations (1)

Seoul, South Korea