ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00620074
Recruitment Status : Terminated (See Detailed Description)
First Posted : February 21, 2008
Results First Posted : February 15, 2010
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Aspergillosis Drug: voriconazole Drug: anidulafungin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Summary of Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 42) ]

Secondary Outcome Measures :
  1. Summary of Global Response at Week 2, Week 4, and Week 6 [ Time Frame: Week 2, Week 4, Week 6 ]
  2. Summary of Mortality [ Time Frame: Up to Week 6 ]
  3. Galactomannan Titer Assay Levels and Global Response [ Time Frame: Up to Week 6 ]
  4. Voriconazole Trough Levels With Intravenous and Oral Dosing [ Time Frame: Week 1 through Week 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00620074     History of Changes
Other Study ID Numbers: A8851014
First Posted: February 21, 2008    Key Record Dates
Results First Posted: February 15, 2010
Last Update Posted: February 15, 2010
Last Verified: January 2010

Keywords provided by Pfizer:
invasive aspergillosis, opportunistic mold infection

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors