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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Childrens Hospital Los Angeles
Los Angeles, California, 90027 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Aspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00836875
Pfizer
Terminated
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

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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
Masking: None (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.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czechia,   Netherlands,   Poland,   Singapore,   Spain,   Thailand,   United States
Bulgaria,   Czech Republic,   Germany,   Hungary
 
NCT00836875
A1501080
2008-005275-10 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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