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

Sponsored by:	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 IV

Drug Information available for: Voriconazole Anidulafungin

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint will be global response consisting of a combination of clinical and radiological findings at the end of therapy. [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess voriconazole levels with IV and oral dosing [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
To evaluate mortality and global response at Weeks 2, 4, 6. [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of combination therapy with voriconazole and anidulafungin. [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
To compare galactomannan titers (an immunological test performed on blood serum) with the Global Response. [ Time Frame: Up to 6 weeks ] [ 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
combination 2: Experimental 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 200 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 200 mg Q12h).
combination 1: Experimental 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

Arms

Assigned Interventions

combination 2: Experimental

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 200 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 200 mg Q12h).

combination 1: Experimental

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

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:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8851014
Study First Received:	February 8, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00620074 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

invasive aspergillosis, opportunistic mold infection

Study placed in the following topic categories:

Anti-Bacterial Agents
Mycoses
Clotrimazole
Miconazole
Antifungal Agents

Voriconazole
Tioconazole
Aspergillosis
Anidulafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Therapeutic Uses
Antifungal Agents
Voriconazole

Antibiotics, Antifungal
Aspergillosis
Pharmacologic Actions
Anidulafungin

ClinicalTrials.gov processed this record on May 06, 2009