A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174473
First received: September 12, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

This is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children


Condition Intervention Phase
Neutropenia
Drug: Voriconazole
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Intravenous to Oral Switch, Multiple Dose Multi-Centre Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Hospitalized Children Aged 2 to 12 Years Who Require Treatment for the Prevention of Systemic Fungal Infections.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary objective was to investigate the pharmacokinetics of voriconazole following intravenous (iv) to oral administration in immunocompromised children aged 2 to <12years.

Secondary Outcome Measures:
  • The secondary objective was to evaluate the safety and tolerability of multiple dose administration of voriconazole in immunocompromised children requiring treatment for the prevention of systemic fungal infection.

Enrollment: 49
Study Start Date: June 2003
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who require a systemic antifungal agent for the prevention of systemic fungal infection

Exclusion Criteria:

  • Children who are receiving medications which cannot be taken concomitantly with voriconazole.
  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: NCT00174473

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00174473     History of Changes
Other Study ID Numbers: A1501037
Study First Received: September 12, 2005
Last Updated: May 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Voriconazole
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 22, 2014