Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Cresemba to Evaluate Safety and Effectiveness in Patients With Invasive Aspergillosis or Invasive Mucormycosis in Korea
Pfizer
600 participants
Oct 28, 2021
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
Patients who are treated with Isavuconazole according to its protocol label.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04744454