A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

Phase 3TerminatedNCT00836875

Pfizer31 enrolled

Overview

The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Invasive Aspergillosis

Interventions

VoriconazoleDRUG

All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy. Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator. Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \<50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Immunocompromised with clinically compatible illness. * Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions). * Diagnosis of infection due to Scedosporium or Fusarium species. * Male and female from 2 to 17 years of age. * Females with childbearing potential must have negative pregnancy test and be using appropriate contraception. Exclusion Criteria: * Allergy or hypersensitivity to the azole drugs. * Female subjects who are pregnant or lactating. * Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection. * Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation. * Significant liver, kidney or heart dysfunction. * Not expected to survive for at least 5 days.

Locations (25)

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Time frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment

Secondary Outcomes

Percentage of Participants With a Global Response of Success

Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to \<90% resolution of the radiological lesions attributed to IA at Baseline.

Time frame: Weeks 6 and End of Treatment (EOT; up to Week 12)

All-Cause Mortality - Number of Participant Deaths

Number of participant deaths reported at Week 6 and at EOT (up to Week 12).

Time frame: Week 6 and EOT (up to Week 12)

Attributable Mortality - Number of Participant Deaths

Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).

Time frame: Weeks 6 and EOT (up to Week 12)

Time to Death

Time frame: Baseline up to 1 month post treatment

Data from ClinicalTrials.gov

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Childrens Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital & Research Center Oakland (CHRCO)

Oakland, California, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Children's Pavilion, Virginia Commonwealth University Health System