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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 July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
Information provided by (Responsible Party):
Pfizer Identifier:
First received: March 10, 2010
Last updated: May 17, 2016
Last verified: May 2016
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
Masking: None (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 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:
  • Percentage of Participants With Adverse Events - Overall Summary [ Time Frame: Baseline up to 1 month follow-up ]
    Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.

Secondary Outcome Measures:
  • Percentage of Participants With a Global Response of Success at End of Treatment (EOT) [ Time Frame: EOT (from 7 to 42 days of treatment) ]
    Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.

  • All-Cause Mortality - Number of Participant Deaths [ Time Frame: Day 28 and 1 Month Follow-up ]
  • Time to Death [ Time Frame: Baseline up to 1 month follow-up ]

Enrollment: 23
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: May 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


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01092832

China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Beijing Children's Hospital, Capital University of Medical Sciences
Beijing, China, 100045
Czech Republic
Fakultni nemocnice Brno - Klinika detske onkologie
Brno, Czech Republic, 625 00
Hong Kong
Department of Paediatrics and Adolescent Medicine
Hong Kong, Hong Kong, 0
Queen Mary Hospital
Hong Kong, Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, N.T., Hong Kong
Semmelweis Egyetem, II. sz. Szemeszeti Klinika
Budapest, Hungary, 1085
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary, 1094
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
Budapest, Hungary, 1097
Instituto Nacional de Pediatria
Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, DF, Mexico, 04530
Medical Research Laboratory Philippine General Hospital University of the Philippines
Ermita,, Manila, Philippines, 1000
Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
Manila, Philippines, 1000
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
Olsztyn, Poland, 10-561
Detska fakultna nemocnica s poliklinikou Bratislava
Bratislava, Slovakia, 833 40
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01092832     History of Changes
Other Study ID Numbers: A1501085
2009-012848-16 ( EudraCT Number )
Study First Received: March 10, 2010
Results First Received: June 2, 2014
Last Updated: May 17, 2016

Keywords provided by Pfizer:
Invasive Candidiasis Candidemia Esophageal Candidiasis

Additional relevant MeSH terms:
Candidiasis, Invasive
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
Cytochrome P-450 CYP3A Inhibitors processed this record on September 21, 2017