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Trial record 28 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

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)

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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

Tracking Information
First Submitted Date  ICMJE February 8, 2008
First Posted Date  ICMJE February 21, 2008
Results First Submitted Date  ICMJE January 21, 2010
Results First Posted Date  ICMJE February 15, 2010
Last Update Posted Date February 15, 2010
Study Start Date  ICMJE August 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
Summary of Global Response at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 42) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
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 ]
Change History Complete list of historical versions of study NCT00620074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2010)
  • Summary of Global Response at Week 2, Week 4, and Week 6 [ Time Frame: Week 2, Week 4, Week 6 ]
  • Summary of Mortality [ Time Frame: Up to Week 6 ]
  • Galactomannan Titer Assay Levels and Global Response [ Time Frame: Up to Week 6 ]
  • Voriconazole Trough Levels With Intravenous and Oral Dosing [ Time Frame: Week 1 through Week 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
  • To evaluate the safety and tolerability of combination therapy with voriconazole and anidulafungin. [ Time Frame: Up to 6 weeks ]
  • To compare galactomannan titers (an immunological test performed on blood serum) with the Global Response. [ Time Frame: Up to 6 weeks ]
  • To assess voriconazole levels with IV and oral dosing [ Time Frame: Up to 6 weeks ]
  • To evaluate mortality and global response at Weeks 2, 4, 6. [ Time Frame: Up to 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aspergillosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: combination 2
    anidulafungin plus voriconazole
    Intervention: Drug: voriconazole
  • Experimental: combination 1
    anidulafungin plus voriconazole
    Intervention: Drug: anidulafungin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)
6
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2008)
50
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00620074
Other Study ID Numbers  ICMJE A8851014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP