Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

PHASE4CompletedINTERVENTIONAL
Enrollment

282

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions
Candidiasis
Interventions
DRUG

Eraxis (anidulafungin)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

DRUG

Diflucan (fluconazole)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.

DRUG

Vfend (voriconazole)

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Trial Locations (43)

12208

Pfizer Investigational Site, Albany

14263

Pfizer Investigational Site, Buffalo

14642

Pfizer Investigational Site, Rochester

15213

Pfizer Investigational Site, Pittsburgh

19140

Pfizer Investigational Site, Philadelphia

19611

Pfizer Investigational Site, West Reading

19713

Pfizer Investigational Site, Newark

19718

Pfizer Investigational Site, Newark

19801

Pfizer Investigational Site, Wilmington

20010

Pfizer Investigational Site, Washington D.C.

21205

Pfizer Investigational Site, Baltimore

21287

Pfizer Investigational Site, Baltimore

27834

Pfizer Investigational Site, Greenville

29414

Pfizer Investigational Site, Charleston

30322

Pfizer Investigational Site, Atlanta

32209

Pfizer Investigational Site, Jacksonville

32801

Pfizer Investigational Site, Orlando

32806

Pfizer Investigational Site, Orlando

32819

Pfizer Investigational Site, Orlando

33136

Pfizer Investigational Site, Miami

35233

Pfizer Investigational Site, Birmingham

35294

Pfizer Investigational Site, Birmingham

48073

Pfizer Investigational Site, Royal Oak

48201

Pfizer Investigational Site, Detroit

48202

Pfizer Investigational Site, Detroit

55455

Pfizer Investigational Site, Minneota

59701

Pfizer Investigational Site, Butte

62701

Pfizer Investigational Site, Springfield

62702

Pfizer Investigational Site, Springfield

62703

Pfizer Investigational Site, Springfield

72205

Pfizer Investigational Site, Little Rock

77030

Pfizer Investigational Site, Houston

90033

Pfizer Investigational Site, Los Angeles

94115

Pfizer Investigational Site, San Francisco

94143

Pfizer Investigational Site, San Francisco

97239

Pfizer Investigational Site, Portland

62703-9248

Pfizer Investigational Site, Springfield

08103

Pfizer Investigational Site, Camden

27834-6028

Pfizer Investigational Site, Greenville

120-752

Pfizer Investigational Site, Seoul

135-710

Pfizer Investigational Site, Seoul

137-701

Pfizer Investigational Site, Seoul

138-736

Pfizer Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY