Clinical trial NCT04744454: Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aspergillosis
Mucormycosis
Keywords: Aspergillosis
Mucormycosis
Isavuconazole
Korean
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Detailed description: In compliance with the Korean New Drug Re-Examination Guidelines, this study aims to collect further observational data on the safety and effectiveness of Cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. As the safety and effectiveness results obtained from the clinical development program of Cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where Cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in Korea. This non-interventional study is designated as a PMS study and is a commitment to MFDS.

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.

Primary outcomes:
measure: Adverse event (AE) as safety evaluation
timeFrame: Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.
Secondary outcomes:
measure: Effectiveness evaluation
timeFrame: From baseline to end of treatment or up to 12 weeks, whichever comes first.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: