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

Last updated: May 17, 2016
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

Gynecological Infections

Systemic Fungal Infections

Vaginal Infection

Treatment

N/A

Clinical Study ID

NCT01092832
A1501085
2009-012848-16
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permittedto enroll in this study only after a Pfizer sponsored pharmacokinetic study confirmsthe proposed dosage corresponding to this age group is appropriate.

  • Patients with confirmed Candida infection of the blood, body tissues, or theesophagus.

  • Patient's doctor feels voriconazole is an appropriate choice of therapy.

Exclusion

Exclusion Criteria:

  • A known allergy to voriconazole or to azole to antifungal drugs.

  • Females who are pregnant, lactating (breast feeding) or planning a pregnancy duringthe course of the study, or who are of childbearing potential and not using highlyeffective method of birth control.

  • A patient who is receiving treatment with a drug know to interfere with the heart'selectrical system (QTc prolongation).

  • A patient who is receiving treatment with a drug that is not permitted to be used withvoriconazole.

  • For primary therapy: a patient who has received more than 48 hours of antifungaltherapy for the current episode of Candida infection.

  • A patient with significant underlying liver disease at the time of enrollment in thestudy.

  • A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollmentin the study.

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

Study Design

Total Participants: 23
Study Start date:
October 01, 2010
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Hospital de Clinicas da Universidade Federal do Parana HC-UFPR

    Curitiba, PR 80060-900
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer

    Porto Alegre, RS 90035-074
    Brazil

    Site Not Available

  • Hospital de Base - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto (FUNFARME)

    Sao Jose do Rio Preto, SP 15090-000
    Brazil

    Site Not Available

  • Klinika po detski i genetichni zaboliavania, UMBAL "Sveti Georgi" Plovdiv

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • SBALPFZ - Ruse EOOD, Pnevmologichno otdelenie

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Hematologichno otdelenie, SBALDOHZ-Sofia

    Sofia, 1527
    Bulgaria

    Site Not Available

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Beijing Children's Hospital, Capital University of Medical Sciences

    Beijing, 100045
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiatong University School of Medicne/Pediatric Department

    Shanghai, 200092
    China

    Site Not Available

  • Department for Oncology and Hematology,University Hospital "Sestre Milosrdnice"

    Zagreb, 10000
    Croatia

    Site Not Available

  • Fakultni nemocnice Brno - Klinika detske onkologie

    Brno, 625 00
    Czech Republic

    Site Not Available

  • Zentrum fuer Kinderheilkunde der Universitaet Bonn Abteilung Haematologie/Onkologie

    Bonn, 53113
    Germany

    Site Not Available

  • Zentrum fuer Kinder- und Jugendmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Department of Paediatrics and Adolescent Medicine

    Hong Kong, 0
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Department of Paediatrics

    New Territories, 0
    Hong Kong

    Site Not Available

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Shatin, N.T.,
    Hong Kong

    Site Not Available

  • Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

    Budapest, 1097
    Hungary

    Site Not Available

  • Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika

    Budapest, 1094
    Hungary

    Site Not Available

  • Semmelweis Egyetem, II. sz. Szemeszeti Klinika

    Budapest, 1085
    Hungary

    Site Not Available

  • Department of Paediatrics

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Instituto Nacional de Pediatria

    Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, DF 04530
    Mexico

    Site Not Available

  • Hospital Infantil de Mexico Federico Gomez

    Mexico, DF 06720
    Mexico

    Site Not Available

  • Medical Research Laboratory Philippine General Hospital University of the Philippines

    Ermita,, Manila 1000
    Philippines

    Site Not Available

  • Chong Hua Hospital

    Cebu City, 6000
    Philippines

    Site Not Available

  • Davao Doctors Hospital

    Davao City, 8000
    Philippines

    Site Not Available

  • Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila

    Manila, 1000
    Philippines

    Site Not Available

  • Philippine Children's Medical Center

    Quezon City, 1100
    Philippines

    Site Not Available

  • Klinika Onkologii i Hematologii Dzieciecej

    Bialystok, 15-274
    Poland

    Site Not Available

  • Katedra i Klinika Pediatrii, Alergologii i Gastroenterologii

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Klinika Pediatrii, Hematologii, Onkologii i Endokrynologii

    Gdansk, 80-952
    Poland

    Site Not Available

  • Klinika Hematologii i Onkologii Dzieciecej

    Lublin, 20-093
    Poland

    Site Not Available

  • Oddzial Pediatryczny I- Hematologiczno-Onkologiczny

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Institutul Clinic Fundeni, Clinica Pediatrie

    Bucuresti, Sector 2 022328
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta pentru Copii, Sf. Maria, Clinica IV Pediatrie, Hemato-Oncologie

    Iasi, 700309
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Pediatrie III

    Timisoara, 300011
    Romania

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Detska fakultna nemocnica s poliklinikou Bratislava

    Bratislava, 833 40
    Slovakia

    Site Not Available

  • Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

    Patumwan, Bangkok 10330
    Thailand

    Site Not Available

  • Division of Hematology and Oncology

    Bangkok, 10700
    Thailand

    Site Not Available

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