Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
CandidiasisCandidemia
Interventions
DRUG

voriconazole (Vfend)

"Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h~Notes:~1. If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.~2. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.~(IV = Intravenous; POS = Powder for oral suspension)"

Trial Locations (14)

21215

Pfizer Investigational Site, Baltimore

27710

Pfizer Investigational Site, Durham

30322

Pfizer Investigational Site, Atlanta

32207

Pfizer Investigational Site, Jacksonville

37232

Pfizer Investigational Site, Nashville

44106

Pfizer Investigational Site, Cleveland

70118

Pfizer Investigational Site, New Orleans

77030

Pfizer Investigational Site, Houston

85719

Pfizer Investigational Site, Tucson

85724

Pfizer Investigational Site, Tucson

92868

Pfizer Investigational Site, Orange

97239

Pfizer Investigational Site, Portland

30322-1062

Pfizer Investigational Site, Atlanta

30342-1600

Pfizer Investigational Site, Atlanta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY