Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Aspergillosis Clinical Trial

Official title:

A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531479
• Other study ID #: A8851009
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2007
• Last updated: April 3, 2012
• Start date: July 2008
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis

Intervention

Drug:
• voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
• anidulafungin
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
• voriconazole
First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Herston	Queensland
Australia	Pfizer Investigational Site	Westmead	New South Wales
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Leuven
Belgium	Pfizer Investigational Site	Yvoir
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Czech Republic	Pfizer Investigational Site	Praha 2
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Creteil
France	Pfizer Investigational Site	GRENOBLE Cedex 09
France	Pfizer Investigational Site	Marseille	Cedex 09
France	Pfizer Investigational Site	Nantes	Cedex 01
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Rouen Cedex
France	Pfizer Investigational Site	Strasbourg
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bremen
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Frankfurt (Oder)
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Homburg/Saar
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Wuerzburg
Greece	Pfizer Investigational Site	Thessaloniki
India	Pfizer Investigational Site	Pune	Maharashtra
Italy	Pfizer Investigational Site	Cuneo
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Perugia
Italy	Pfizer Investigational Site	Pescara
Italy	Pfizer Investigational Site	Roma
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Netherlands	Pfizer Investigational Site	RC Leiden
Peru	Pfizer Investigational Site	Lima
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Warszawa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint Petersburg
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
Spain	Pfizer Investigational Site	Badalona	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Salamanca
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Switzerland	Pfizer Investigational Site	Geneve 14
Switzerland	Pfizer Investigational Site	Lausanne
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kuei-Shan Hsiang	Taoyuan County
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok
Turkey	Pfizer Investigational Site	Adana
Turkey	Pfizer Investigational Site	Ankara
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Chapel Hill	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	LaJolla	California
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Greece,  India,  Italy,  Korea, Republic of,  Netherlands,  Peru,  Poland,  Portugal,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis	Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.	Day 1 to Day 42 (Week 6)	Yes
Secondary	Global Response at 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.	Baseline, Day 42 (Week 6)	No
Secondary	All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)	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.	Day 1 to Day 42 (Week 6)	Yes
Secondary	All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)	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.	Day 1 to Day 84 (Week 12)	Yes
Secondary	Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA	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.	Day 1 to Day 42 (Week 6)	Yes
Secondary	Time to Death: All-Cause Mortality	Survival time from start of treatment. Time to death defined as date of death due to any cause minus first treatment date + 1.	Day 1 to Day 84 (Week 12)	Yes
Secondary	Time to Death Due to Invasive Aspergillosis (IA)	Survival time from start of treatment. Time to death defined as date of death due to IA minus first treatment date + 1.	Day 1 to Day 84 (Week 12)	Yes

External Links

•   To obtain contact information for a study center near you, click here.