Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
AspergillosisInvasive Pulmonary AspergillosisNeuroaspergillosis
Interventions
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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01188759 - Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects | Biotech Hunter | Biotech Hunter