Aspergillosis, Candidiasis, Cryptococcosis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections
Interventions
DRUGVoriconazole
Oral or intravenous voriconazole. Oral tablets 400 mg twice daily loading dose on first day, followed by 200 mg twice daily taken at least 1 hour before or after a meal. Oral doses could be increased to a maximum of 300 mg twice daily if there was no clinical improvement after at least 3 days of treatment, no serious adverse events were reported, and clinical chemistry parameters were within the acceptable range for study entry. Intravenous treatment was initiated with a loading dose of 6 mg/kg twice daily for the first day followed by 4 mg/kg twice daily for at least 3 days (maximum infusion rate of 3 mg/kg/hr if administered by peripheral intravenous line). An intravenous loading dose was not required in patients who were restarted after oral treatment. Total duration of therapy (intravenous and oral) was 12 weeks.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy. | Weeks 2, 8, 12, and end of therapy |
| 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. | Weeks 1, 2, 4, 8, 12 and end of therapy |
| 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. | Weeks 2, 8, 12, and end of therapy |
| Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy. | Weeks 2, 8, 12, and end of therapy |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in electrocardiogram at Week 1 and end of therapy. | Week 1 and end of therapy |
| Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up. | Weeks 1, 8, 12, end of therapy, Week 16, and follow-up |
| Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up. | Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up |
| Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up. | Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up |
| Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16. | End of therapy or Week 16 |
Countries
Taiwan
Outcome results
None listed