Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2010
CompletedFirst Posted
Study publicly available on registry
August 25, 2010
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 11, 2012
May 1, 2012
2.3 years
August 24, 2010
May 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
12 weeks
Secondary Outcomes (4)
Rate of all-cause mortality at 6 weeks
6 weeks
Rate of all-cause mortality at EOT
12 weeks
Global response to therapy at 6 weeks
6 weeks
Global response to therapy at EOT
12 weeks
Study Arms (2)
Voriconazole and Anidulafungin Combination
EXPERIMENTALSubjects 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.
Voriconazole Monotherapy
ACTIVE COMPARATORSubjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of proven, probable, or possible invasive aspergillosis.
- Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
You may not qualify if:
- Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Chronic invasive aspergillosis.
- Receipt of antifungal treatment for more than 96 hours.
- Severe liver dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2010
First Posted
August 25, 2010
Study Start
May 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 11, 2012
Record last verified: 2012-05