This trial is active, not recruiting.

Condition systemic fungal infections
Treatments parenteral micafungin application, other parenteral antifungal drugs
Sponsor Astellas Pharma Europe B.V.
Collaborator World Health Information Science Consultants, LLC
Start date October 2012
End date April 2020
Trial size 35000 participants
Trial identifier NCT01686607, 9463-CL-1401


This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
parenteral micafungin application
other parenteral antifungal drugs 'other antifungals' include the following drugs:

Primary Outcomes

Treatment-emergent hepatic injury or dysfunction
time frame: Up to 30 days after termination of the index treatment
Treatment-emergent renal failure or dysfunction
time frame: Up to 30 days after termination of the index treatment
Rehospitalization for the parenteral treatment of fungal infections
time frame: Up to 30 days after termination of the index treatment
Death from hepatocellular carcinoma (HCC)
time frame: Up to 13 years after treatment

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - hospitalized and treated with parenteral antifungal medication - first time treatment of the patient with parenteral antifungal in the medical center was anytime from 2005 through 2012 Exclusion Criteria: - prior diagnosis of hepatocellular carcinoma - had received parenteral antifungal therapy during the 6 months prior to index hospitalization

Additional Information

Official title A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Principal investigator Lead Investigator
Description All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.