CompletedNot Applicable

Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

United States40,110 participantsStarted 2012-10-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment-emergent hepatic injury or dysfunction

Timeframe: Up to 30 days after termination of the index treatment

Treatment-emergent renal failure or dysfunction

Timeframe: Up to 30 days after termination of the index treatment

Rehospitalization for the parenteral treatment of fungal infections

Timeframe: Up to 30 days after termination of the index treatment

Death from hepatocellular carcinoma (HCC)

Timeframe: Up to 13 years after treatment

Trial details

NCT IDNCT01686607

SponsorAstellas Pharma Europe B.V.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-04-30

View on ClinicalTrials.gov More Systemic Fungal Infections trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment-emergent hepatic injury or dysfunction

Timeframe: Up to 30 days after termination of the index treatment

Treatment-emergent renal failure or dysfunction

Timeframe: Up to 30 days after termination of the index treatment

Rehospitalization for the parenteral treatment of fungal infections

Timeframe: Up to 30 days after termination of the index treatment

Death from hepatocellular carcinoma (HCC)

Timeframe: Up to 13 years after treatment