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Cresemba under the microscope: Real-World safety check for fungal infections

NCT ID NCT04744454

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how safe and effective the drug Cresemba (isavuconazole) is for Korean patients with serious fungal infections like invasive aspergillosis or mucormycosis. Researchers tracked side effects and how well the drug worked in 94 adults. The goal was to confirm the drug's safety and effectiveness in real-world use, as required by Korean health authorities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Isavuconazole (brand name Cresemba)
What this could lead to
If results are positive, it could confirm that Cresemba is a safe and effective option for treating serious fungal infections in Korean patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also small (94 people) and only in Korea, so findings may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

94 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aspergillosis invasive aspergillosis Zygomycosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aspergillosis Mucormycosis

Contacts and locations

Locations

  • Pfizer Korea

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.