Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
NCT ID: NCT01188759
Last Updated: 2012-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Voriconazole and Anidulafungin Combination
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.
Voriconazole
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
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.
Voriconazole Monotherapy
Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
Voriconazole
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.
Interventions
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Voriconazole
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
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.
Voriconazole
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.
Eligibility Criteria
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Inclusion Criteria
* Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
Exclusion Criteria
* Chronic invasive aspergillosis.
* Receipt of antifungal treatment for more than 96 hours.
* Severe liver dysfunction.
2 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1501095
Identifier Type: -
Identifier Source: org_study_id
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