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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

Primary Purpose

Candidiasis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Invasive Candidiasis Candidemia Esophageal Candidiasis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Beijing Children's Hospital, Capital University of Medical Sciences
  • Fakultni nemocnice Brno - Klinika detske onkologie
  • Department of Paediatrics and Adolescent Medicine
  • Queen Mary Hospital
  • The Chinese University of Hong Kong, Prince of Wales Hospital
  • Semmelweis Egyetem, II. sz. Szemeszeti Klinika
  • Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
  • Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
  • Instituto Nacional de Pediatria
  • Medical Research Laboratory Philippine General Hospital University of the Philippines
  • Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
  • Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
  • Detska fakultna nemocnica s poliklinikou Bratislava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active voriconazole

Arm Description

All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events - Overall Summary
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)
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 to Death

Full Information

First Posted
March 10, 2010
Last Updated
May 17, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01092832
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
Keywords
Invasive Candidiasis Candidemia Esophageal Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active voriconazole
Arm Type
Experimental
Arm Description
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
Intervention Type
Drug
Intervention Name(s)
voriconazole
Other Intervention Name(s)
Vfend
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events - Overall Summary
Description
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.
Time Frame
Baseline up to 1 month follow-up
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Global Response of Success at End of Treatment (EOT)
Description
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.
Time Frame
EOT (from 7 to 42 days of treatment)
Title
All-Cause Mortality - Number of Participant Deaths
Time Frame
Day 28 and 1 Month Follow-up
Title
Time to Death
Time Frame
Baseline up to 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Beijing Children's Hospital, Capital University of Medical Sciences
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Fakultni nemocnice Brno - Klinika detske onkologie
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Department of Paediatrics and Adolescent Medicine
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin, N.T.
Country
Hong Kong
Facility Name
Semmelweis Egyetem, II. sz. Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Instituto Nacional de Pediatria
City
Colonia Insurgentes Cuicuilco, Delegacion Coyoacan
State/Province
DF
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Medical Research Laboratory Philippine General Hospital University of the Philippines
City
Ermita,
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Detska fakultna nemocnica s poliklinikou Bratislava
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27636722
Citation
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. doi: 10.1097/INF.0000000000001339.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501085&StudyName=A%20Study%20Of%20The%20Safety%2C%20Tolerability%20And%20Effective%20Of%20Voriconazole%20For%20The%20Treatment%20Of%20Serious%20Candida%20Infection%20And%20Candida%20Infection
Description
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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

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