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

Launched by PFIZER · Feb 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Cresemba for patients in Korea who have serious fungal infections known as invasive Aspergillosis or invasive Mucormycosis. The researchers want to see how well Cresemba works in real-world settings after it has been approved for use. The trial is currently looking for participants who are at least 19 years old and have either a confirmed or suspected diagnosis of these fungal infections.

To join the study, patients need to provide written consent indicating they understand the study's details. However, certain individuals cannot participate, such as those who have a known allergy to Cresemba or specific health conditions. Participants in this trial will receive the medication and be monitored to help the researchers gather information about how safe and effective it is for people with these conditions. It's an important study that could help improve treatment options for patients with serious fungal infections.

Gender

ALL

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.