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

Phase 3

Terminated

• Conditions: Candidiasis
• Interventions: Drug: voriconazole

• Registration Number: NCT01092832
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-25
• Study Start: 2010-10
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Results First Submitted: 2014-06-02
• Results First Submitted QC: 2015-08-10
• Results First Posted: 2015-08-17
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events - Overall Summary	Baseline up to 1 month follow-up	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

Name	Time	Method
Percentage of Participants With a Global Response of Success at End of Treatment (EOT)	EOT (from 7 to 42 days of treatment)	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	Day 28 and 1 Month Follow-up
Time to Death	Baseline up to 1 month follow-up

Trial Locations

Locations (14)

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

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, Czech Republic

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

Detska fakultna nemocnica s poliklinikou Bratislava; 🇸🇰 Bratislava, Slovakia

Instituto Nacional de Pediatria; 🇲🇽 Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, DF, Mexico

Oddzial Pediatryczny I- Hematologiczno-Onkologiczny; 🇵🇱 Olsztyn, Poland

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