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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voriconazole and Anidulafungin Combination | Experimental | Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy. |
|
| Voriconazole Monotherapy | Active Comparator | Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events | 12 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D055744 | Invasive Pulmonary Aspergillosis |
| D020953 | Neuroaspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D055732 | Pulmonary Aspergillosis |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| D000077612 | Anidulafungin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Anidulafungin | Drug | 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 | Drug | 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. |
|
| 6 weeks |
| Global response to therapy at EOT | 12 weeks |
| D000072742 |
| Invasive Fungal Infections |
| D008172 | Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020314 | Central Nervous System Fungal Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |