An Observational Study of Patients Receiving Therapy for Systemic Fungal Infections

Condition(s) targeted: Scedosporium; Aspergillosis (Invasive Pulmonary, Extrapulmonary); Fusarium; Candidiasis

Intervention: voriconazole (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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 SFI in India.

Official title: A Study of Indian Patients Receiving Therapy For Systemic Fungal Infections

Study design: Other, Prospective

Primary outcome:

Clinical and mycological outcomes

Management: Choice of treatment, dose and reason for selection of antifungal

Diagnosis: Evidence of SFI (clinical features, radiological evidence, microbiological evidence), end organ dysfunction (if any)

Secondary outcome:

demography data

safety data (adverse events, concomitant medication, treatment administration details)

Detailed description: This is a non-interventional observational study. The observation period will end once the outcome of the last patient has been recorded. To be eligible for enrollment in the study database, patients must have received (in the 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

To be eligible for enrollment in the study database, patients must have received (in the 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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To obtain contact information for a study center near you, click here.

Starting date: January 2009
Ending date: March 2009
Last updated: January 16, 2009