You are here

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

Last updated on December 4, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Invasive Aspergillosis
Intervention  ICMJE 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.

Study Arms  ICMJE 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
Publications *Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2013)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2009)
36
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion DateMay 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Netherlands,   Poland,   Singapore,   Spain,   Thailand,   United States
Removed Location CountriesBulgaria,   Czech Republic,   Germany,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT00836875
Other Study ID Numbers  ICMJE A1501080
2008-005275-10 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now