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

Astellas

Status and phase: Withdrawn; Phase 4

Conditions: Aspergillosis/Invasive; Aspergillosis/Blood

Treatments: Drug: micafungin; Drug: voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423163

20-05-002

Details and patient eligibility

About

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

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind