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

Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00836875
• Other study ID #: A1501080
• Status: Terminated
• Phase: Phase 3
• First received: February 3, 2009
• Last updated: June 19, 2014
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Calgary	Alberta
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Brno
Netherlands	Pfizer Investigational Site	Nijmegen
Poland	Pfizer Investigational Site	Wroclaw
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Madrid
Thailand	Pfizer Investigational Site	Bangkok noi	Bangkok
Thailand	Pfizer Investigational Site	Patumwan	Bangkok
Thailand	Pfizer Investigational Site	Rajathevee	Bangkok
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Oakland	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Netherlands,  Poland,  Singapore,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)		Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment	Yes
Secondary	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.	Weeks 6 and End of Treatment (EOT; up to Week 12)	No
Secondary	All-Cause Mortality - Number of Participant Deaths	Number of participant deaths reported at Week 6 and at EOT (up to Week 12).	Week 6 and EOT (up to Week 12)	Yes
Secondary	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).	Weeks 6 and EOT (up to Week 12)	Yes
Secondary	Time to Death		Baseline up to 1 month post treatment	Yes

External Links

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