Clinical trial NCT00647907: A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
Official title: An Open Label, Non-comparative, Multicenter Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Candidiasis
Cryptococcosis
Aspergillosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections


Eligibility criteria: Inclusion Criteria:

* Systemic or invasive fungal infection
* Infection caused by organism for which there is no current treatment or infection with evidence of failure and/or intolerance to treatment with approved antifungal agents

Exclusion Criteria:

* Liver function test abnormalities
* Renal disease
* Fungal infections not considered to be invasive or systemic

Primary outcomes:
measure: Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.
timeFrame: Weeks 2, 8, 12, and end of therapy
measure: Clinical response (evaluated based on change of attributable symptoms, signs, and/or bronchoscopic abnormalities present at baseline, judged by investigators, at Weeks 1, 2, 4, 8, 12, and end of therapy) at Weeks 1, 2, 4, 8, 12, and end of therapy.
timeFrame: Weeks 1, 2, 4, 8, 12 and end of therapy
measure: Radiological response (evaluated based on all radiological abnormalities [X-ray, computed tomography scan] attributed to fungal infection compared to baseline) at Weeks 2, 8, 12, and end of therapy.
timeFrame: Weeks 2, 8, 12, and end of therapy
measure: Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.
timeFrame: Weeks 2, 8, 12, and end of therapy
Secondary outcomes:
measure: Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.
timeFrame: End of therapy or Week 16
measure: Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
timeFrame: Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up
measure: Change from baseline in electrocardiogram at Week 1 and end of therapy.
timeFrame: Week 1 and end of therapy
measure: Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
timeFrame: Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up
measure: Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.
timeFrame: Weeks 1, 8, 12, end of therapy, Week 16, and follow-up
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: