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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00836875

Purpose

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.

Condition	Intervention	Phase
Invasive Aspergillosis	Drug: Voriconazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Open-Label, Non-Randomized, Multi-Center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The primary endpoint is safety and tolerability throughout the study including the follow-up visit. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of global response at 6 weeks and End of Treatment (EOT). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
All cause and attributable mortality at 6 weeks and EOT. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Time to death. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).	Drug: Voriconazole 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.

Arms

Assigned Interventions

Experimental: 1

Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).

Drug: Voriconazole

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

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836875

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 39 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:	NCT00836875 History of Changes
Other Study ID Numbers:	A1501080
Study First Received:	February 3, 2009
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Additional relevant MeSH terms:

Aspergillosis
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 February 09, 2012