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

NCT04744454 | Completed

• 2 other identifiers: C3791006NCT04744454
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Aspergillosis; Mucormycosis

Keywords

Aspergillosis; Mucormycosis; Isavuconazole; Korean

Outcome Measures

Primary Outcomes (1)

• Adverse event (AE) as safety evaluation

  Incidence of the adverse events from baseline in all patients who received at least one dose of Isavuconazole and completed safety follow up will be assessed. AEs will be analyzed by preferred term coding.

  Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.

Secondary Outcomes (1)

• Effectiveness evaluation

  From baseline to end of treatment or up to 12 weeks, whichever comes first.

Interventions

Isauvuconazole group DRUG

Patients who are treated with Isavuconazole according to its protocol label.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is performed in accordance with routine clinical practice as per regulatory requirement. Therefore, inclusion and exclusion criteria relate to the labelled indication and contraindications. (Refer to the most updated version of the local product document \[LPD\]) All patients initiated on Isavuconazole and provided informed consent to the study will be enrolled continuously up to the planned number of enrolled patients. The assignment of the patient to Isavuconazole is decided by the investigator if he/she considers administering as per the current practice would provide clinical benefit with regards to safety and effectiveness.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Korea

Seoul, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Aspergillosis; Mucormycosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Zygomycosis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 9, 2021
• Study Start: October 28, 2021
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)