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

Phase 3

Terminated

• Conditions: Invasive Aspergillosis
• Interventions: Drug: Voriconazole

• Registration Number: NCT00836875
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Study Start: 2009-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2014-06-19
• Results First Posted: 2014-06-23
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to Death	Baseline up to 1 month post treatment
Percentage of Participants With a Global Response of Success	Weeks 6 and End of Treatment (EOT; up to Week 12)	Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to \<90% resolution of the radiological lesions attributed to IA at Baseline.
All-Cause Mortality - Number of Participant Deaths	Week 6 and EOT (up to Week 12)	Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
Attributable Mortality - Number of Participant Deaths	Weeks 6 and EOT (up to Week 12)	Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).

Trial Locations

Locations (24)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Patumwan, Bangkok, Thailand

Department of Pediatrics, Phramongkutklao hospital; 🇹🇭 Rajathevee, Bangkok, Thailand

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Children's Hospital & Research Center Oakland (CHRCO); 🇺🇸 Oakland, California, United States

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Pavilion, Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Pediatric Hematology and Oncology, Virginia Commonwealth University Health System; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University Health System, Hospital Pharmacy; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University/MCV Clinical Pathology; 🇺🇸 Richmond, Virginia, United States

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej; 🇵🇱 Wroclaw, Poland

Fakultni nemocnice Brno; 🇨🇿 Brno, Czechia

National University Hospital; 🇸🇬 Singapore, Singapore

Alberta Children's Hospital, Pediatric Oncology Office; 🇨🇦 Calgary, Alberta, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands

Hospital General Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore

Hospital Universitari Vall d'Hebron. Servicio de Farmacia; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia; 🇪🇸 Madrid, Spain

Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok noi, Bangkok, Thailand

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain