Observing the safety and effectiveness of Cresemba in Korea for fungal infections.
Official title: 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
Run by Pfizer · NCT04744454 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how safe and effective Cresemba is for people in Korea with serious fungal infections like Aspergillosis or Mucormycosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04744454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients aged 19 years or older with a proven or suspected diagnosis of invasive Aspergillosis or invasive Mucormycosis.
✕Probably not a fit
Patients with known hypersensitivity to Isavuconazole or those taking contraindicated medications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to monitor the safety and effectiveness of Cresemba (Isavuconazole) in patients diagnosed with invasive Aspergillosis or Mucormycosis in Korea. Conducted over six years, it will gather data from at least 600 subjects under routine clinical practice, as mandated by the Korean Ministry of Food and Drug Safety. The study is designed to provide insights into the drug's performance in a real-world setting, complementing previous randomized trials that had specific inclusion criteria. By focusing on post-marketing surveillance, the study seeks to enhance understanding of Cresemba's safety profile and therapeutic effectiveness.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the real-world effectiveness and safety of Cresemba for patients with serious fungal infections.
How similar studies have gone: Other studies have shown success with similar observational approaches, particularly in post-marketing surveillance settings.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Pfizer Korea
Seoul, Korea, Republic of Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.