Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01188759
• Other study ID #: A1501095
• Status: Withdrawn
• Phase: Phase 3
• First received: August 24, 2010
• Last updated: May 10, 2012
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Pulmonary Aspergillosis
• Neuroaspergillosis
• Pulmonary Aspergillosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events		12 weeks	Yes
Secondary	Rate of all-cause mortality at 6 weeks		6 weeks	Yes
Secondary	Rate of all-cause mortality at EOT		12 weeks	Yes
Secondary	Global response to therapy at 6 weeks		6 weeks	Yes
Secondary	Global response to therapy at EOT		12 weeks	Yes

External Links

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