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
NCT ID: NCT01092832
Last Updated: 2016-06-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
23 participants
INTERVENTIONAL
2010-10-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Active voriconazole
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Beijing Children's Hospital, Capital University of Medical Sciences
Beijing, , China
Fakultni nemocnice Brno - Klinika detske onkologie
Brno, , Czechia
Department of Paediatrics and Adolescent Medicine
Hong Kong, , Hong Kong
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
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, , Hungary
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
Budapest, , Hungary
Instituto Nacional de Pediatria
Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, Mexico City, Mexico
Medical Research Laboratory Philippine General Hospital University of the Philippines
Ermita, Manila, Philippines
Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
Manila, , Philippines
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
Olsztyn, , Poland
Detska fakultna nemocnica s poliklinikou Bratislava
Bratislava, , Slovakia
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2009-012848-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A1501085
Identifier Type: -
Identifier Source: org_study_id
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