Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00620074

Purpose

This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

Condition	Intervention	Phase
Aspergillosis	Drug: voriconazole Drug: anidulafungin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase IV Open-Label Pilot Study to Evaluate the Combination of Voriconazole and Anidulafungin for the Treatment of Subjects With Proven or Probable Invasive Aspergillosis Who Are Intolerant of Polyene Treatment

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Drug Information available for: Voriconazole Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Summary of Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 42) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Summary of Global Response at Week 2, Week 4, and Week 6 [ Time Frame: Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
Summary of Mortality [ Time Frame: Up to Week 6 ] [ Designated as safety issue: Yes ]
Galactomannan Titer Assay Levels and Global Response [ Time Frame: Up to Week 6 ] [ Designated as safety issue: No ]
Voriconazole Trough Levels With Intravenous and Oral Dosing [ Time Frame: Week 1 through Week 6 ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	August 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: combination 2 anidulafungin plus voriconazole	Drug: voriconazole Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Other Name: Vfend
Experimental: combination 1 anidulafungin plus voriconazole	Drug: anidulafungin Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy Other Name: Eraxis

Arms

Assigned Interventions

Experimental: combination 2

anidulafungin plus voriconazole

Drug: voriconazole

Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).

Other Name: Vfend

Experimental: combination 1

anidulafungin plus voriconazole

Drug: anidulafungin

Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Other Name: Eraxis

Detailed Description:

The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Proven or probable invasive aspergillosis. Patient is intolerant to polyene therapy.

Exclusion Criteria:

Patients with invasive aspergillosis for more than 30 days at the time of study entry. Patients with uncontrolled bacterial or viral infection at the time of study entry. Patients with significant liver dysfunction or who are taking certain medications which interact with voriconazole.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620074

Locations

United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Texas
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104
Pfizer Investigational Site
Fort Worth, Texas, United States, 76107

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00620074 History of Changes
Other Study ID Numbers:	A8851014
Study First Received:	February 8, 2008
Results First Received:	January 21, 2010
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

invasive aspergillosis, opportunistic mold infection

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012