NCT00836875
Terminated
Phase 3
A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.
Overview
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 31
- Locations
- 24
- Primary Endpoint
- Number of Participants With Adverse Events (AEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: Voriconazole (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs)
Time Frame: 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
- 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))
- 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))
Investigators
Study Sites (24)
Loading locations...
Similar Trials
Completed
Phase 3
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal InfectionsAspergillosisCandidiasisFungemiaMycosesNCT00001810National Cancer Institute (NCI)300
Terminated
Phase 3
Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous LeukemiaLeukemia, Myelocytic, AcuteNCT00152594University of Cologne150
Terminated
Phase 3
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 PatientsCandidiasisNCT01092832Pfizer23
Terminated
Phase 4
Voriconazole as Prophylactic Therapy in Lung Transplant RecipientsInfectionNCT00455364University of Chicago20
Completed
Phase 3
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)Antifungal Prophylaxis of Invasive Fungal InfectionsNCT00289991Pfizer489