Clinical trial · Observational
Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
NCT01686607CI-TRIAL-00081779MYCOScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Fungal Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other parenteral antifungal drugs | Drug | — | UNRESOLVED |
| Parenteral micafungin application | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1) parenteral micafungin users
- description
- patients who had been treated with parenteral micafungin
- interventionNames
- Drug: Parenteral micafungin application
- label
- 2) other parenteral antifungal users
- description
- patients who had been treated with a parenteral antifungal agent (not micafungin)
- interventionNames
- Drug: Other parenteral antifungal drugs
Primary outcomes (4)
- measure
- Treatment-emergent hepatic injury or dysfunction
- timeFrame
- Up to 30 days after termination of the index treatment
- description
- Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.