A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

This study has been terminated.
(This protocol terminated prematurely on Jul 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01092832
First received: March 10, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.


Condition Intervention Phase
Candidiasis
Drug: voriconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Non-Comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Treatment Of Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of voriconazole, as determined by the rate of adverse events (serious and non-serious), including visual-, cardiac-, and liver related adverse effects, and treatment discontinuation due to adverse events. [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy, as determined by global response at the End of Treatment (EOT). [ Time Frame: 7 - 42 days ] [ Designated as safety issue: No ]
  • Time to death and all-cause mortality during study therapy. [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: Yes ]
  • Exploratory Analysis: Correlation between CYP2C19 genotype status and voriconazole exposure [ Time Frame: 1 - 72 Days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active voriconazole
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
Drug: voriconazole

Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.

Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).

Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.

Other Name: Vfend

  Eligibility

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

Inclusion Criteria:

  • Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
  • Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
  • Patient's doctor feels voriconazole is an appropriate choice of therapy.

Exclusion Criteria:

  • A known allergy to voriconazole or to azole to antifungal drugs.
  • Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
  • A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
  • A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
  • For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
  • A patient with significant underlying liver disease at the time of enrollment in the study.
  • A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollment in the study.
  • A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.
  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: NCT01092832

Locations
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
China
Beijing Children's Hospital, Capital University of Medical Sciences
Beijing, China, 100045
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic, 625 00
Fakultni nemocnice Brno
Brno, Czech Republic, 62500
Hong Kong
Department of Paediatrics and Adolescent Medicine
Hong Kong, Hong Kong, 0
Department of Paediatrics
New Territories, Hong Kong, 0
Hungary
Semmelweis Egyetem, II. sz. Szemeszeti Klinika
Budapest, Hungary, 1085
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
Budapest, Hungary, 1097
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary, 1094
Mexico
Instituto Nacional de Pediatria
Mexico, DF, Mexico, 04530
Philippines
Philippine General Hospital University of the Philippines Manila
Manila, Philippines, 1000
Poland
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
Olsztyn, Poland, 10-561
Slovakia
Detska fakultna nemocnica s poliklinikou Bratislava
Bratislava, Slovakia, 833 40
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: NCT01092832     History of Changes
Other Study ID Numbers: A1501085
Study First Received: March 10, 2010
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Invasive Candidiasis Candidemia Esophageal Candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
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 August 01, 2014