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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01188759
Other study ID # A1501095
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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