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Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

NCT00634049•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Detailed Description

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants meeting EORTC/MSG (European Organization for the Research and Treatment of Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive fungal disease) caused by rare moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.
•OR
•Participants who had proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.
•OR
•Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were refractory to current treatment defined as,
•Clear documentation of progression of disease. Note: radiological progression only in association with white blood cell (WBC) count recovery was not acceptable.
•Failure to improve clinically despite receiving at least 7 days of standard antifungal regimen. Prior to enrolling patients who fell into this category, the Medical Monitor was contacted for approval.
•OR
•Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were intolerant to current treatment for example:
•Doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours.
+3 more criteria

Exclusion Criteria

•A known condition of the participants that may jeopardize adherence to the protocol requirements
•Participants who are unlikely to survive 30 days
•Participants with a body weight \< 40 kg
•Women who are pregnant or breastfeeding

Locations (96)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City Of Hope National Medical Center

Duarte, California, United States

University of California Davis Health System

Sacramento, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford University Hospital

Stanford, California, United States

University Of Colorado Health Sciences Center

Aurora, Colorado, United States

Emory Hospital

Atlanta, Georgia, United States

University of Chicago, Division of Infectious Diseases

Chicago, Illinois, United States

Indiana BMT

Beech Grove, Indiana, United States

Key Dates

Start Date

April 22, 2008

Primary Completion Date

January 3, 2014

Completion Date

May 5, 2016

Last Updated

December 11, 2024

Enrollment

149

ACTUAL participants

Conditions

AspergillosisInvasive Fungal Infections

Interventions

isavuconazole

DRUG

Influenza Associated Aspergillosis In-depth Investigation

NCT03748069

Influenza With PneumoniaInvasive Pulmonary Aspergillosis

View study

RECRUITING

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

NCT06105411

Invasive Fungal Infections

View study

RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Inclusion Criteria

Exclusion Criteria

Influenza Associated Aspergillosis In-depth Investigation

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

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