NCT01686607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,110

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

October 21, 2024

Status Verified

May 1, 2019

Enrollment Period

5.6 years

First QC Date

September 13, 2012

Last Update Submit

October 18, 2024

Conditions

Systemic Fungal Infections

Keywords

Hepatic toxicityRenal toxicityMicafunginHepatocellular carcinomaAntifungals (parenteral)

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to 13 years after treatment

Study Arms (2)

1) parenteral micafungin users

patients who had been treated with parenteral micafungin

Drug: Parenteral micafungin application

2) other parenteral antifungal users

patients who had been treated with a parenteral antifungal agent (not micafungin)

Drug: Other parenteral antifungal drugs

Interventions

Parenteral micafungin applicationDRUG

Parenteral

1) parenteral micafungin users
Other parenteral antifungal drugsDRUG

Parenteral

Also known as: caspofungin, anidulafungin, fluconazole, itraconazole, voriconazole, amphotericin B (various formulations), 'other antifungals' include the following drugs:
2) other parenteral antifungal users

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with parenteral antifungals in tertiary referral centers across the United States.

You may qualify if:

  • 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

You may not qualify if:

  • prior diagnosis of hepatocellular carcinoma
  • had received parenteral antifungal therapy during the 6 months prior to index hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site US4

Baltimore, Maryland, 21205, United States

Location

Site US2

Boston, Massachusetts, 02119, United States

Location

Site US6

Ann Arbor, Michigan, 48109, United States

Location

Site US3

Durham, North Carolina, 27710, United States

Location

Site US5

Philadelphia, Pennsylvania, 19104, United States

Location

Site US1

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

CaspofunginAnidulafunginFluconazoleItraconazoleVoriconazoleAmphotericin B

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Lead Investigator

    WHISCON, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

October 1, 2012

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

October 21, 2024

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

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/.

Locations

US(6)