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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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NCT01092832

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female 2 to 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 in the study.

- A patient with a high likelihood of death within 72 hours of study enrollment due to
factors unrelated to Candida infection.

NCT01092832
Pfizer
Terminated
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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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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Candidiasis
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
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
June 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
China,   Czech Republic,   Hong Kong,   Hungary,   Mexico,   Philippines,   Poland,   Slovakia
Argentina,   Brazil,   Bulgaria,   Croatia,   Germany,   Malaysia,   Romania,   Singapore,   Thailand
 
NCT01092832
A1501085
2009-012848-16 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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