Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis - Full Text View

Purpose

The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.

Condition	Intervention	Phase
Aspergillosis	Drug: Micafungin Drug: Liposomal Amphotericin B	Phase II

Drug Information available for:

Amphotericin B Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of treatment response defined as complete or partial response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Radiological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Mycological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Survival at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Enrollment:	2
Study Start Date:	December 2002
Study Completion Date:	February 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Micafungin IV Drug: Liposomal Amphotericin B IV

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy

Exclusion Criteria

Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
Has life expectancy of less than five days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047827

Locations


United States, District of Columbia

	Washington, District of Columbia, United States, 20010

United States, Georgia

	Atlanta, Georgia, United States, 30322

United States, Michigan

	Detroit, Michigan, United States, 48201

	Ann Arbor, Michigan, United States, 48109

United States, Missouri

	St. Louis, Missouri, United States, 63110

United States, Tennessee

	Memphis, Tennessee, United States, 38105

United States, Texas

	Houston, Texas, United States, 77030

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Central Contact	Astellas Pharma US, Inc.

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	01-0-125, FG463-21-11
First Received:	October 18, 2002
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00047827
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Aspergillus

Aspergillosis

Anti-Fungal

AmBisome

Micafungin

Study placed in the following topic categories:

Abelcet

Amphotericin B

Mycoses

Clotrimazole

Miconazole

AmBisome

Tioconazole

Aspergillosis

Micafungin

Additional relevant MeSH terms:

Anti-Bacterial Agents

Anti-Infective Agents

Antiparasitic Agents

Antiprotozoal Agents

Antifungal Agents

Therapeutic Uses

Antibiotics, Antifungal

Amebicides

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 27, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00047827