Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Phase 3

Completed

• Conditions: Aspergillosis
• Interventions: Drug: voriconazole; Drug: anidulafungin

• Registration Number: NCT00531479
• Lead Sponsor: Pfizer

Brief Summary

This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-18
• Study Start: 2008-07
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Status Verified: 2012-04
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-04-03
• Last Update Submitted: 2012-04-03
• Results First Posted: 2012-04-30
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

• Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
• Diagnosis of possible, probable, or proven invasive aspergillosis.

Exclusion Criteria

• Patients with aspergilloma or chronic aspergillosis
• Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
• Anticipated survival of less than 5 days or Karnofsky score <=20

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voriconazole	voriconazole	Voriconazole monotherapy
Voriconazole and Anidulafungin	anidulafungin	Combination therapy with voriconazole and anidulafungin
Voriconazole and Anidulafungin	voriconazole	Combination therapy with voriconazole and anidulafungin

Primary Outcome Measures

Name	Time	Method
All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis	Day 1 to Day 42 (Week 6)	Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.

Secondary Outcome Measures

Name	Time	Method
Global Response at Week 6	Baseline, Day 42 (Week 6)	Number of participants with a successful response (complete or partial global response). Complete response = resolution of all clinical signs and symptoms and \>90% of lesions due to IA that were visible on radiologic studies at baseline (BL); partial response = clinical improvement and \>50% improvement in radiological findings present at BL.
All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)	Day 1 to Day 42 (Week 6)	Number of deaths due to any cause measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)	Day 1 to Day 84 (Week 12)	Number of deaths due to any cause measured 12 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA	Day 1 to Day 42 (Week 6)	Number of deaths due to Invasive Aspergillosis measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
Time to Death: All-Cause Mortality	Day 1 to Day 84 (Week 12)	Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.
Time to Death Due to Invasive Aspergillosis (IA)	Day 1 to Day 84 (Week 12)	Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom