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

This study has been terminated.
(This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00836875
First received: February 3, 2009
Last updated: June 19, 2014
Last verified: June 2014

February 3, 2009
June 19, 2014
May 2009
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
The primary endpoint is safety and tolerability throughout the study including the follow-up visit. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00836875 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With a Global Response of Success [ Time Frame: Weeks 6 and End of Treatment (EOT; up to Week 12) ] [ Designated as safety issue: No ]
    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.
  • All-Cause Mortality - Number of Participant Deaths [ Time Frame: Week 6 and EOT (up to Week 12) ] [ Designated as safety issue: Yes ]
    Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
  • Attributable Mortality - Number of Participant Deaths [ Time Frame: Weeks 6 and EOT (up to Week 12) ] [ Designated as safety issue: Yes ]
    Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).
  • Time to Death [ Time Frame: Baseline up to 1 month post treatment ] [ Designated as safety issue: Yes ]
  • Rate of global response at End of Treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All cause mortality at 6 and 12 weeks. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Time to death. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Description of the serum Aspergillus galactomannan antigenemia at EOT in relation to global response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Invasive Aspergillosis
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.

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).
Intervention: Drug: Voriconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Netherlands,   Poland,   Singapore,   Spain,   Thailand
 
NCT00836875
A1501080
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP