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

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01092832
• Other study ID #: A1501085
• Secondary ID: 2009-012848-16
• Status: Terminated
• Phase: Phase 3
• First received: March 10, 2010
• Last updated: August 10, 2015
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital University of Medical Sciences	Beijing
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
Czech Republic	Fakultni nemocnice Brno - Klinika detske onkologie	Brno
Hong Kong	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.
Hungary	Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet	Budapest
Hungary	Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika	Budapest
Hungary	Semmelweis Egyetem, II. sz. Szemeszeti Klinika	Budapest
Mexico	Instituto Nacional de Pediatria	Colonia Insurgentes Cuicuilco, Delegacion Coyoacan	DF
Philippines	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
Poland	Oddzial Pediatryczny I- Hematologiczno-Onkologiczny	Olsztyn
Slovakia	Detska fakultna nemocnica s poliklinikou Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Czech Republic,  Hong Kong,  Hungary,  Mexico,  Philippines,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events - Overall Summary	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.	Baseline up to 1 month follow-up	Yes
Secondary	Percentage of Participants With a Global Response of Success at End of Treatment (EOT)	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.	EOT (from 7 to 42 days of treatment)	No
Secondary	All-Cause Mortality - Number of Participant Deaths		Day 28 and 1 Month Follow-up	No
Secondary	Time to Death		Baseline up to 1 month follow-up	No

External Links

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