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Trial record 1 of 1 for:    NCT01092832
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01092832
Recruitment Status : Terminated (This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.)
First Posted : March 25, 2010
Results First Posted : August 17, 2015
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 10, 2010
First Posted Date  ICMJE March 25, 2010
Results First Submitted Date  ICMJE June 2, 2014
Results First Posted Date  ICMJE August 17, 2015
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • Efficacy, as determined by global response at the End of Treatment (EOT). [ Time Frame: 7 - 42 days ]
  • Time to death and all-cause mortality during study therapy. [ Time Frame: 1 - 72 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Candidiasis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Active voriconazole
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
Intervention: Drug: voriconazole
Publications * Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 10, 2015)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
30
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Czech Republic,   Hong Kong,   Hungary,   Mexico,   Philippines,   Poland,   Slovakia
Removed Location Countries Argentina,   Brazil,   Bulgaria,   Croatia,   Germany,   Malaysia,   Romania,   Singapore,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT01092832
Other Study ID Numbers  ICMJE A1501085
2009-012848-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP