A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections

NCT00288197

Invasive Fungal Infections

COMPLETED PHASE4

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 Infections

NCT00001810

Aspergillosis Candidiasis Fungemia +1 more

COMPLETED PHASE3

Study to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)

NCT00620074

Aspergillosis

TERMINATED PHASE4

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 Infections

NCT00001757

Mycoses

COMPLETED PHASE3

Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection

NCT01137292

Invasive Fungal Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Candidiasis Cryptococcosis Aspergillosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Voriconazole

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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