Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
Primary Purpose
Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Voriconazole
Anidulafungin
Voriconazole
Sponsored by
About this trial
This is an interventional treatment trial for Aspergillosis focused on measuring Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of proven, probable, or possible invasive aspergillosis.
- Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
Exclusion Criteria:
- Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Chronic invasive aspergillosis.
- Receipt of antifungal treatment for more than 96 hours.
- Severe liver dysfunction.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Voriconazole and Anidulafungin Combination
Voriconazole Monotherapy
Arm Description
Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.
Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
Outcomes
Primary Outcome Measures
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
Secondary Outcome Measures
Rate of all-cause mortality at 6 weeks
Rate of all-cause mortality at EOT
Global response to therapy at 6 weeks
Global response to therapy at EOT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188759
Brief Title
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
Official Title
A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
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
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
Keywords
Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voriconazole and Anidulafungin Combination
Arm Type
Experimental
Arm Description
Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.
Arm Title
Voriconazole Monotherapy
Arm Type
Active Comparator
Arm Description
Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
Voriconazole therapy is to be given for 6-12 weeks.
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Intervention Description
Anidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg).
Anidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole.
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
Voriconazole therapy is to be given for 6-12 weeks.
Primary Outcome Measure Information:
Title
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality at 6 weeks
Time Frame
6 weeks
Title
Rate of all-cause mortality at EOT
Time Frame
12 weeks
Title
Global response to therapy at 6 weeks
Time Frame
6 weeks
Title
Global response to therapy at EOT
Time Frame
12 weeks
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:
Diagnosis of proven, probable, or possible invasive aspergillosis.
Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
Exclusion Criteria:
Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
Chronic invasive aspergillosis.
Receipt of antifungal treatment for more than 96 hours.
Severe liver dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501095&StudyName=Voriconazole%20And%20Anidulafungin%20Combination%20For%20Invasive%20Aspergillosis%20In%20Pediatric%20Subjects
Description
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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
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