Voriconazole to Treat Fungal Infections

NCT00001940 | Completed Phase 3

• 2 other identifiers: 00002400-C-0024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients. Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop. Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.

Conditions

Mycoses

Keywords

Antifungal Agent; Aspergillosis; Candidemia; Fungemia

Interventions

Voriconazole DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Males or (non-pregnant, lactating and nursing) females equal to or greater than 12 years of age. Previous enrollment into and completion of voriconazole therapy in protocol 99-C-0094 investigating the use of voriconazole in the treatment of invasive fungal disease or empirical treatment of presumed fungal infections and enrolled within three weeks of completion of 99-C-0094B. Clinical benefit was derived from previous voriconazole treatment. Further clinical benefit is expected with extended voriconazole treatment. Women of child bearing potential (or less than 2 years post- menopausal) must have a negative serum pregnancy test at baseline, and must agree to use barrier methods of contraception during the study. Signed written informed consent must be obtained at protocol entry. Assent will be obtained from minors capable of understanding. Subjects must not have either ongoing serious adverse events probably related to voriconazole therapy or have ongoing adverse events probably related to voriconazole therapy which may pose a significant risk on continued therapy. Must not have previously participated in this trial. If receiving, must be able to discontinue the following drugs at least 24 hours prior to randomization: terfenadine, cisapride, and astemizole. If receiving, must be able to discontinue sulphonylureas at least 24 hours prior to randomization. Must not have received the following drugs within 14 days prior to randomization: rifampin, carbamazepine, or barbiturates. Must not have AST, ALT, greater than 10 (upper limit normal). Must not have serum creatinine greater than 3.0 mg/dl.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Mycoses; Aspergillosis; Candidemia; Fungemia

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Candidiasis, Invasive; Candidiasis; Invasive Fungal Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: December 10, 2002
• Study Start: December 1, 1999
• Study Completion: July 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-11

Locations

US (1)