NCT01188759

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Neuroaspergillosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-08-25
• Last updated: 2012-05-11