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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01188759

Enrollment

Registered

2010-08-25

Start date

2012-05-31

Completion date

2014-08-31

Last updated

2012-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis

Keywords

Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin

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.

Interventions

DRUGVoriconazole

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.

DRUGAnidulafungin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events	12 weeks

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026