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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Candidiasis	Drug: voriconazole	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Open-Label, Non-Comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Treatment Of Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders Yeast Infections

Drug Information available for: Voriconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of voriconazole, as determined by the rate of adverse events (serious and non-serious), including visual-, cardiac-, and liver related adverse effects, and treatment discontinuation due to adverse events. [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy, as determined by global response at the End of Treatment (EOT). [ Time Frame: 7 - 42 days ] [ Designated as safety issue: No ]
Time to death and all-cause mortality during study therapy. [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: Yes ]
Exploratory Analysis: Correlation between CYP2C19 genotype status and voriconazole exposure [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active voriconazole All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.	Drug: voriconazole 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. Other Name: Vfend

Arms

Assigned Interventions

Experimental: Active voriconazole

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

Drug: voriconazole

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.

Other Name: Vfend

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092832

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 28 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01092832 History of Changes
Other Study ID Numbers:	A1501085
Study First Received:	March 10, 2010
Last Updated:	April 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Invasive Candidiasis Candidemia Esophageal Candidiasis

Additional relevant MeSH terms:

Candidiasis
Candidiasis, Invasive
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013