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 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Percentage of Participants With Adverse Events - Overall Summary [ Time Frame: Baseline up to 1 month follow-up ] [ Designated as safety issue: Yes ]Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose reduced or temporarily discontinued due to AEs.
- Percentage of Participants With a Global Response of Success at End of Treatment (EOT) [ Time Frame: EOT (from 7 to 42 days of treatment) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Time to Death [ Time Frame: Baseline up to 1 month follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Active voriconazole
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092832
|Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology|
|Wuhan, Hubei, China, 430030|
|Beijing Children's Hospital, Capital University of Medical Sciences|
|Beijing, China, 100045|
|Fakultni nemocnice Brno - Klinika detske onkologie|
|Brno, Czech Republic, 625 00|
|Department of Paediatrics and Adolescent Medicine|
|Hong Kong, Hong Kong, 0|
|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, 1085|
|Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika|
|Budapest, Hungary, 1094|
|Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet|
|Budapest, Hungary, 1097|
|Instituto Nacional de Pediatria|
|Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, DF, Mexico, 04530|
|Medical Research Laboratory Philippine General Hospital University of the Philippines|
|Ermita,, Manila, Philippines, 1000|
|Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila|
|Manila, Philippines, 1000|
|Oddzial Pediatryczny I- Hematologiczno-Onkologiczny|
|Olsztyn, Poland, 10-561|
|Detska fakultna nemocnica s poliklinikou Bratislava|
|Bratislava, Slovakia, 833 40|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|