Trial record 1 of 102 for:    "Aspergillosis"
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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01188759
First received: August 24, 2010
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Aspergillosis
Invasive Pulmonary Aspergillosis
Neuroaspergillosis
Drug: Voriconazole
Drug: Anidulafungin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of all-cause mortality at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Rate of all-cause mortality at EOT [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Global response to therapy at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Global response to therapy at EOT [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Voriconazole and Anidulafungin Combination
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.
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.

Active Comparator: Voriconazole Monotherapy
Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
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.


  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188759

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01188759     History of Changes
Other Study ID Numbers: A1501095
Study First Received: August 24, 2010
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Aspergillosis
Combination Therapy
Voriconazole
Anidulafungin

Additional relevant MeSH terms:
Aspergillosis
Invasive Pulmonary Aspergillosis
Pulmonary Aspergillosis
Neuroaspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Fungal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014