A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

Phase 4

Withdrawn

• Conditions: Aspergillosis/Blood; Aspergillosis/Invasive

• Registration Number: NCT00423163
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Study Start: 2007-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Proven, probable or possible invasive aspergillosis
• Patient is 2 years of age or older

Exclusion Criteria

• The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for >7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
• The patient has been treated with voriconazole for > 7 days immediately prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.

Secondary Outcome Measures

Name	Time	Method
Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome