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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

Primary Purpose

Invasive Aspergillosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Aspergillosis focused on measuring Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Childrens Hospital Los Angeles
  • Children's Hospital & Research Center Oakland (CHRCO)
  • Children's Hospital of Pittsburgh of UPMC
  • The University of Texas MD Anderson Cancer Center
  • Children's Pavilion, Virginia Commonwealth University Health System
  • Virginia Commonwealth University Health System, Hospital Pharmacy
  • Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
  • Virginia Commonwealth University/MCV Clinical Pathology
  • Virginia Commonwealth University
  • Alberta Children's Hospital, Pediatric Oncology Office
  • Alberta Children's Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Brno
  • UMC St. Radboud
  • Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
  • National University Hospital
  • KK Women's and Children's Hospital
  • Hospital General Universitari Vall D'Hebron
  • Hospital Universitari Vall d'Hebron. Servicio de Farmacia
  • Hospital Universitario Vall d'Hebron
  • HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia
  • Hospital Universitario 12 de Octubre
  • Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
  • Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
  • Department of Pediatrics, Phramongkutklao hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

Secondary Outcome Measures

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.
All-Cause Mortality - Number of Participant Deaths
Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
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).
Time to Death

Full Information

First Posted
February 3, 2009
Last Updated
May 23, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00836875
Brief Title
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.
Study Start Date
May 2009 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis
Keywords
Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Global Response of Success
Description
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.
Time Frame
Weeks 6 and End of Treatment (EOT; up to Week 12)
Title
All-Cause Mortality - Number of Participant Deaths
Description
Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
Time Frame
Week 6 and EOT (up to Week 12)
Title
Attributable Mortality - Number of Participant Deaths
Description
Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).
Time Frame
Weeks 6 and EOT (up to Week 12)
Title
Time to Death
Time Frame
Baseline up to 1 month post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital & Research Center Oakland (CHRCO)
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Pavilion, Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Virginia Commonwealth University Health System, Hospital Pharmacy
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0042
Country
United States
Facility Name
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University/MCV Clinical Pathology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Alberta Children's Hospital, Pediatric Oncology Office
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Hospital General Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron. Servicio de Farmacia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Department of Pediatrics, Phramongkutklao hospital
City
Rajathevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
27636722
Citation
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. doi: 10.1097/INF.0000000000001339.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501080&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20Of%20Voriconazole%20As%20Treatment%20Of%20Invasive%20Aspergillosis%20%28Fungal%20Infection%29%20And%20Other%20Rare%20Molds%20In%20C
Description
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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

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