Trials Sponsors Conditions Drugs Pricing

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:

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

Sponsors & Collaborators

World Health Information Science Consultants, LLC
Othercollaborator
Astellas Pharma Europe B.V.
Industrylead

Study Sites (6)

Site US4

Baltimore, Maryland, 21205, United States

Site US2

Boston, Massachusetts, 02119, United States

Site US6

Ann Arbor, Michigan, 48109, United States

Site US3

Durham, North Carolina, 27710, United States

Site US5

Philadelphia, Pennsylvania, 19104, United States

Site US1

Pittsburgh, Pennsylvania, 15213, United States

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

CaspofunginAnidulafunginFluconazoleItraconazoleVoriconazoleAmphotericin B

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System Neoplasms

Study Officials

Lead Investigator
WHISCON, LLC
PRINCIPAL INVESTIGATOR

Enrollment

40,110 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

1) parenteral micafungin users

2) other parenteral antifungal users

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (2)

1) parenteral micafungin users

2) other parenteral antifungal users

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations