A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
Condition: Candidiasis
MeSH terms: Candidiasis
Intervention: voriconazole
Intervention description: Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.
Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).
Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.
Intervention MeSH terms: Voriconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Invasive Candidiasis Candidemia Esophageal Candidiasis

Summary:

      The purpose of this study is to determine whether voriconazole is safe and effective for the
      treatment of serious Candida infection and Candida infection of the esophagus in children and
      adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted
             to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms
             the proposed dosage corresponding to this age group is appropriate.

          -  Patients with confirmed Candida infection of the blood, body tissues, or the
             esophagus.

          -  Patient's doctor feels voriconazole is an appropriate choice of therapy.

        Exclusion Criteria:

          -  A known allergy to voriconazole or to azole to antifungal drugs.

          -  Females who are pregnant, lactating (breast feeding) or planning a pregnancy during
             the course of the study, or who are of childbearing potential and not using highly
             effective method of birth control.

          -  A patient who is receiving treatment with a drug know to interfere with the heart's
             electrical system (QTc prolongation).

          -  A patient who is receiving treatment with a drug that is not permitted to be used with
             voriconazole.

          -  For primary therapy: a patient who has received more than 48 hours of antifungal
             therapy for the current episode of Candida infection.

          -  A patient with significant underlying liver disease at the time of enrollment in the
             study.

          -  A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollment
             in the study.

          -  A patient with a high likelihood of death within 72 hours of study enrollment due to
             factors unrelated to Candida infection.