Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT01092832
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT01092832
Study Brief:
Protocol Section:
NCT01092832