A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

Study Overview
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Brief Summary
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To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India.

Official Title
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An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections

Conditions
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Systemic Fungal Infections

Intervention / Treatment
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* Drug: voriconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Drug: voriconazole<br>* Patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.<br>* Other names: Vfend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Systemic Fungal Infection (SFI) | Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator. | Up to 9 months | 
| Management of SFI: Choice of Treatment | Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator. | Up to 9 months | 
| Management of SFI: Reason for Selection of Antifungal Agent | Number of participants with reason for investigator's selection of particular antifungal therapy. | Up to 9 months | 
| Total Daily Dose for Selected Antifungal Agent |  | Up to 9 months | 
| Number of Participants With Clinical Outcomes. | Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation. | Up to 9 months | 
| Number of Participants With Mycological Outcomes | Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician. | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant Medications |  | Up to 9 months | 
| Median Duration of Antifungal Therapy |  | Up to 9 months | 
| Medication Administration | Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration. | Up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational study, Effectiveness, Safety, Tolerability, Systemic Fungal Infection