A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Overview
- Phase
- Not Applicable
- Intervention
- Parenteral micafungin application
- Conditions
- Systemic Fungal Infections
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 40110
- Locations
- 6
- Primary Endpoint
- Treatment-emergent hepatic injury or dysfunction
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1) parenteral micafungin users
patients who had been treated with parenteral micafungin
Intervention: Parenteral micafungin application
2) other parenteral antifungal users
patients who had been treated with a parenteral antifungal agent (not micafungin)
Intervention: Other parenteral antifungal drugs
Outcomes
Primary Outcomes
Treatment-emergent hepatic injury or dysfunction
Time Frame: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Treatment-emergent renal failure or dysfunction
Time Frame: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Rehospitalization for the parenteral treatment of fungal infections
Time Frame: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Death from hepatocellular carcinoma (HCC)
Time Frame: Up to 13 years after treatment
On a long-term basis up to 13 years from 2005-2017.