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

NCT01092832 | Terminated Phase 3 Results DMC

• 2 other identifiers: A15010852009-012848-16
• Study Type: interventional
• Target: 23
• Locations: 8 countries
• Sites: 14

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.

Conditions

Candidiasis

Keywords

Invasive Candidiasis Candidemia Esophageal Candidiasis

Outcome Measures

Primary Outcomes (1)

• 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 redued or temporarily discontinued due to AEs.

  Baseline up to 1 month follow-up

Secondary Outcomes (3)

• Percentage of Participants With a Global Response of Success at End of Treatment (EOT)

  EOT (from 7 to 42 days of treatment)

• All-Cause Mortality - Number of Participant Deaths

  Day 28 and 1 Month Follow-up

• Time to Death

  Baseline up to 1 month follow-up

Study Arms (1)

Active voriconazole

EXPERIMENTAL

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

Drug: voriconazole

Interventions

voriconazole DRUG

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.

Also known as: Vfend

Active voriconazole

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

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

Wuhan, Hubei, 430030, China

Location

Beijing Children's Hospital, Capital University of Medical Sciences

Beijing, 100045, China

Location

Fakultni nemocnice Brno - Klinika detske onkologie

Brno, 625 00, Czechia

Location

Department of Paediatrics and Adolescent Medicine

Hong Kong, 0, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, N.T., Hong Kong

Location

Semmelweis Egyetem, II. sz. Szemeszeti Klinika

Budapest, 1085, Hungary

Location

Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika

Budapest, 1094, Hungary

Location

Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

Budapest, 1097, Hungary

Location

Instituto Nacional de Pediatria

Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, Mexico City, 04530, Mexico

Location

Medical Research Laboratory Philippine General Hospital University of the Philippines

Ermita, Manila, 1000, Philippines

Location

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

Manila, 1000, Philippines

Location

Oddzial Pediatryczny I- Hematologiczno-Onkologiczny

Olsztyn, 10-561, Poland

Location

Detska fakultna nemocnica s poliklinikou Bratislava

Bratislava, 833 40, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 27636722 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidiasis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was prematurely terminated due to slow enrollment. The study was not terminated due to any safety issues or concerns. Interpretation of the data are limited due to the small sample size and descriptive design.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 25, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 23, 2016
• Results First Posted: August 17, 2015

Record last verified: 2016-05

Locations

PL (1); HK (3); CZ (1); HU (3); ME (1); CN (2); PH (2); SL (1)