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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Candidiasis

Treatments: Drug: voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092832

A1501085

2009-012848-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

23 participants in 1 patient group

Active voriconazole

Experimental group

Description:

All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.

Treatment:

Drug: voriconazole