A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

NCT00836875 | Terminated Phase 3 Results DMC

• 2 other identifiers: A15010802008-005275-10
• Study Type: interventional
• Target: 31
• Locations: 8 countries
• Sites: 25

Brief Summary

The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.

Conditions

Invasive Aspergillosis

Keywords

Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment

Secondary Outcomes (4)

• Percentage of Participants With a Global Response of Success

  Weeks 6 and End of Treatment (EOT; up to Week 12)

• All-Cause Mortality - Number of Participant Deaths

  Week 6 and EOT (up to Week 12)

• Attributable Mortality - Number of Participant Deaths

  Weeks 6 and EOT (up to Week 12)

• Time to Death

  Baseline up to 1 month post treatment

Study Arms (1)

1

EXPERIMENTAL

Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).

Drug: Voriconazole

Interventions

Voriconazole DRUG

All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy. Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator. Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \<50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.

1

Eligibility Criteria

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

You may qualify if:

• Immunocompromised with clinically compatible illness.
• Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
• Diagnosis of infection due to Scedosporium or Fusarium species.
• Male and female from 2 to 17 years of age.
• Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.

You may not qualify if:

• Allergy or hypersensitivity to the azole drugs.
• Female subjects who are pregnant or lactating.
• Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
• Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
• Significant liver, kidney or heart dysfunction.
• Not expected to survive for at least 5 days.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital & Research Center Oakland (CHRCO)

Oakland, California, 94609, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Children's Pavilion, Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

Virginia Commonwealth University Health System, Hospital Pharmacy

Richmond, Virginia, 23298-0042, United States

Location

Pediatric Hematology and Oncology, Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University/MCV Clinical Pathology

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Alberta Children's Hospital, Pediatric Oncology Office

Calgary, Alberta, T3B 6A8, Canada

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Brno

Brno, 62500, Czechia

Location

UMC St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej

Wroclaw, 50-345, Poland

Location

National University Hospital

Singapore, 119074, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Hospital General Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari Vall d'Hebron. Servicio de Farmacia

Barcelona, 08035, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia

Madrid, 28041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

Patumwan, Bangkok, 10330, Thailand

Location

Department of Pediatrics, Phramongkutklao hospital

Rajathevee, Bangkok, 10400, Thailand

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

Interventions

Voriconazole

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: February 3, 2009
• First Posted: February 4, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 16, 2017
• Results First Posted: June 23, 2014

Record last verified: 2017-05

Locations

NL (1); SG (2); CA (2); US (9); CZ (2); TH (3); ES (5); PL (1)