Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infectio

Phase 2

• Conditions: *Aspergillosis, Aspergilloma *Candidemia, Candidiasis *Cryptococcal Meningitis, Pulmonary Cryptococcosis *Fusariosis *Scedosporiosis

• Registration Number: JPRN-jRCT2080221537
• Lead Sponsor: Pfizer Japan Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Male or female from 2 to <15 years of age.
- Require treatment for the prevention of systemic fungal infection.
- Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days following chemotherapy.

Exclusion Criteria

- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia,
hypokalemia, hypomagnesemia or hypocalcemia.
- Documented bacterial or viral infection not responding to appropriate treatment.
- Hypersensitivity to or severe intolerance of azole antifungal agents.
- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified