NCT Number: NCT00721578
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.
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Notify Me18 year–75 year
All sexes
Observational
Pfizer Investigational Site, Pune, Maharashtra, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Vfend
Time frame: Up to 9 months
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Time frame: Up to 9 months
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Time frame: Up to 9 months
Number of participants with reason for investigator's selection of particular antifungal therapy.
Time frame: Up to 9 months
Time frame: Up to 9 months
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.
Time frame: Up to 9 months
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.
Time frame: Up to 9 months
Time frame: Up to 9 months
Time frame: Up to 9 months
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.
Pfizer
Industry
An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
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