A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

Completed

• Conditions: Systemic Fungal Infections
• Interventions: Drug: voriconazole

• Registration Number: NCT00721578
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-07-28
• Results First Submitted QC: 2010-07-29
• Results First Posted: 2010-08-26
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	voriconazole	-

Primary Outcome Measures

Name	Time	Method
Diagnosis of Systemic Fungal Infection (SFI)	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.
Management of SFI: Choice of Treatment	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.
Management of SFI: Reason for Selection of Antifungal Agent	Up to 9 months	Number of participants with reason for investigator's selection of particular antifungal therapy.
Total Daily Dose for Selected Antifungal Agent	Up to 9 months
Number of Participants With Clinical Outcomes.	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.
Number of Participants With Mycological Outcomes	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.

Secondary Outcome Measures

Name	Time	Method
Concomitant Medications	Up to 9 months
Median Duration of Antifungal Therapy	Up to 9 months
Medication Administration	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 New Delhi, India