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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT01188759
Recruitment Status : Withdrawn
First Posted : August 25, 2010
Last Update Posted : May 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Aspergillosis Invasive Pulmonary Aspergillosis Neuroaspergillosis Drug: Voriconazole Drug: Anidulafungin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Rate of all-cause mortality at 6 weeks [ Time Frame: 6 weeks ]
  2. Rate of all-cause mortality at EOT [ Time Frame: 12 weeks ]
  3. Global response to therapy at 6 weeks [ Time Frame: 6 weeks ]
  4. Global response to therapy at EOT [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188759


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01188759     History of Changes
Other Study ID Numbers: A1501095
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by Pfizer:
Aspergillosis
Combination Therapy
Voriconazole
Anidulafungin

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Neuroaspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Invasive Fungal Infections
Central Nervous System Fungal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs