Systemic Fungal InfectionsMYCOSNCT01686607
Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
An observational study of Systemic Fungal Infections, run by Astellas Pharma Europe B.V. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Fungal Infections
- What is being tested?
- Parenteral micafungin application and Other parenteral antifungal drugs
- How many people
- 40,110 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Oct 2012to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with parenteral antifungals in tertiary referral centers across the United States.
Who may be able to join
- 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
Who cannot join
- prior diagnosis of hepatocellular carcinoma
- had received parenteral antifungal therapy during the 6 months prior to index hospitalization
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Site US6
Ann Arbor, Michigan, 48109
Site US4
Baltimore, Maryland, 21205
Site US2
Boston, Massachusetts, 02119
Site US3
Durham, North Carolina, 27710
Site US5
Philadelphia, Pennsylvania, 19104
Site US1
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
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.
Read the 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.
- Conditions
- Systemic Fungal Infections
- Being tested
- Parenteral micafungin application, Other parenteral antifungal drugs
- Keywords
- Hepatic toxicity, Renal toxicity, Micafungin, Hepatocellular carcinoma, Antifungals (parenteral)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral micafungin applicationDrug
Parenteral
Other parenteral antifungal drugsDrug
Also called caspofungin, anidulafungin, fluconazole, itraconazole
Parenteral
| Study group | Role | What they receive |
|---|---|---|
| 1) parenteral micafungin users | patients who had been treated with parenteral micafungin Receives: Drug: Parenteral micafungin application | |
| 2) other parenteral antifungal users | patients who had been treated with a parenteral antifungal agent (not micafungin) Receives: Drug: Other parenteral antifungal drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent hepatic injury or dysfunction
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Measured: Up to 30 days after termination of the index treatment
Treatment-emergent renal failure or dysfunction
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Measured: Up to 30 days after termination of the index treatment
Rehospitalization for the parenteral treatment of fungal infections
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Measured: Up to 30 days after termination of the index treatment
Death from hepatocellular carcinoma (HCC)
On a long-term basis up to 13 years from 2005-2017.
Measured: Up to 13 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start1 Oct 2012
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Health Information Science Consultants, LLC
- Responsible party
- Sponsor
- Investigators
- Lead Investigator, Principal investigator, WHISCON, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686607
- Sponsor's protocol ID
- 9463-CL-1401
- Acronym
- MYCOS
- Status last verified
- May 2019
- First submitted
- 13 Sep 2012
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
- ClinicalTrials.gov ID
- NCT01686607
- Acronym / sponsor ID
- MYCOS / 9463-CL-1401
- Conditions
- Systemic Fungal Infections
- Keywords
- Hepatic toxicity, Renal toxicity, Micafungin, Hepatocellular carcinoma, Antifungals (parenteral)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,110 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Collaborators
- World Health Information Science Consultants, LLC
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) parenteral micafungin users | – | Drug: Parenteral micafungin applicationpatients who had been treated with parenteral micafungin |
| 2) other parenteral antifungal users | – | Drug: Other parenteral antifungal drugspatients who had been treated with a parenteral antifungal agent (not micafungin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with parenteral antifungals in tertiary referral centers across the United States.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- prior diagnosis of hepatocellular carcinoma
- had received parenteral antifungal therapy during the 6 months prior to index hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral micafungin applicationParenteral | Drug | 1) parenteral micafungin users |
| Other parenteral antifungal drugsAlso: caspofungin, anidulafungin, fluconazole, itraconazoleParenteral | Drug | 2) other parenteral antifungal users |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lead Investigator principal investigator
WHISCON, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Fungal Infections, run by Astellas Pharma Europe B.V. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent hepatic injury or dysfunction (time frame: Up to 30 days after termination of the index treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.