Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

PHASE3CompletedINTERVENTIONAL
Enrollment

459

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

April 30, 2011

Study Completion Date

May 31, 2011

Conditions
Aspergillosis
Interventions
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."

DRUG

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."

DRUG

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."

Trial Locations (107)

112

Pfizer Investigational Site, Taipei

333

Pfizer Investigational Site, Kuei-Shan Hsiang

807

Pfizer Investigational Site, Kaohsiung City

1000

Pfizer Investigational Site, Brussels

1011

Pfizer Investigational Site, Lausanne

2145

Pfizer Investigational Site, Westmead

3000

Pfizer Investigational Site, Leuven

4029

Pfizer Investigational Site, Herston

5000

Pfizer Investigational Site, Adelaide

8000

Pfizer Investigational Site, Bruges

10117

Pfizer Investigational Site, Berlin

10330

Pfizer Investigational Site, Bangkok

10400

Pfizer Investigational Site, Bangkok

10700

Pfizer Investigational Site, Bangkok

12100

Pfizer Investigational Site, Cuneo

12200

Pfizer Investigational Site, Berlin

13273

Pfizer Investigational Site, Marseille

14642

Pfizer Investigational Site, Rochester

15236

Pfizer Investigational Site, Frankfurt (Oder)

16132

Pfizer Investigational Site, Genova

19104

Pfizer Investigational Site, Philadelphia

20132

Pfizer Investigational Site, Milan

20162

Pfizer Investigational Site, Milan

20246

Pfizer Investigational Site, Hamburg

21205

Pfizer Investigational Site, Baltimore

21231

Pfizer Investigational Site, Baltimore

21287

Pfizer Investigational Site, Baltimore

27157

Pfizer Investigational Site, Winston-Salem

27514

Pfizer Investigational Site, Chapel Hill

28006

Pfizer Investigational Site, Madrid

28050

Pfizer Investigational Site, Madrid

28177

Pfizer Investigational Site, Bremen

29609

Pfizer Investigational Site, Brest

30322

Pfizer Investigational Site, Atlanta

32610

Pfizer Investigational Site, Gainesville

33136

Pfizer Investigational Site, Miami

35233

Pfizer Investigational Site, Birmingham

35249

Pfizer Investigational Site, Birmingham

37007

Pfizer Investigational Site, Salamanca

38043

Pfizer Investigational Site, Grenoble

44093

Pfizer Investigational Site, Nantes

46010

Pfizer Investigational Site, Valencia

46026

Pfizer Investigational Site, Valencia

48201

Pfizer Investigational Site, Detroit

48202

Pfizer Investigational Site, Detroit

50937

Pfizer Investigational Site, Cologne

55101

Pfizer Investigational Site, Mainz

57010

Pfizer Investigational Site, Thessaloniki

60612

Pfizer Investigational Site, Chicago

60637

Pfizer Investigational Site, Chicago

65100

Pfizer Investigational Site, Pescara

66421

Pfizer Investigational Site, Homburg/Saar

67098

Pfizer Investigational Site, Strasbourg

69120

Pfizer Investigational Site, Heidelberg

72205

Pfizer Investigational Site, Little Rock

75475

Pfizer Investigational Site, Paris

76038

Pfizer Investigational Site, Rouen

77030

Pfizer Investigational Site, Houston

81737

Pfizer Investigational Site, München

92037

Pfizer Investigational Site, La Jolla

92093

Pfizer Investigational Site, La Jolla

94010

Pfizer Investigational Site, Créteil

94143

Pfizer Investigational Site, San Francisco

97080

Pfizer Investigational Site, Würzburg

97239

Pfizer Investigational Site, Portland

98109

Pfizer Investigational Site, Seattle

98195

Pfizer Investigational Site, Seattle

105229

Pfizer Investigational Site, Moscow

115478

Pfizer Investigational Site, Moscow

119074

Pfizer Investigational Site, Singapore

125167

Pfizer Investigational Site, Moscow

169608

Pfizer Investigational Site, Singapore

197089

Pfizer Investigational Site, Saint Petersburg

411004

Pfizer Investigational Site, Pune

92103-8976

Pfizer Investigational Site, San Diego

21231-2410

Pfizer Investigational Site, Baltimore

B-5530

Pfizer Investigational Site, Yvoir

80060-900

Pfizer Investigational Site, Curitiba

21941-913

Pfizer Investigational Site, Rio de Janeiro

90020-090

Pfizer Investigational Site, Porto Alegre

R3A 1R9

Pfizer Investigational Site, Winnipeg

R3E 0V9

Pfizer Investigational Site, Winnipeg

L8N 3Z5

Pfizer Investigational Site, Hamilton

L8V 1C3

Pfizer Investigational Site, Hamilton

H1T 2M4

Pfizer Investigational Site, Montreal

G1R 2J6

Pfizer Investigational Site, Québec

128 20

Pfizer Investigational Site, Prague

01307

Pfizer Investigational Site, Dresden

06134

Pfizer Investigational Site, Perugia

00168

Pfizer Investigational Site, Roma

NL-2300

Pfizer Investigational Site, RC Leiden

Lima 34

Pfizer Investigational Site, Lima

80-952

Pfizer Investigational Site, Gdansk

02-097

Pfizer Investigational Site, Warsaw

1169-050

Pfizer Investigational Site, Lisbon

1649-035

Pfizer Investigational Site, Lisbon

110-744

Pfizer Investigational Site, Seoul

120-752

Pfizer Investigational Site, Seoul

135-710

Pfizer Investigational Site, Seoul

138-736

Pfizer Investigational Site, Seoul

150-713

Pfizer Investigational Site, Seoul

08916

Pfizer Investigational Site, Badalona

CH-1211

Pfizer Investigational Site, Geneva

01330

Pfizer Investigational Site, Adana

06100

Pfizer Investigational Site, Ankara

SE5 9RS

Pfizer Investigational Site, London

M20 4BX

Pfizer Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY