A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections

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.

Study Overview

• Status: Completed
• Conditions: Systemic Fungal Infections
• Intervention / Treatment: Drug: voriconazole

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110 076
    • Pfizer Investigational Site
  • Maharashtra
    • Pune, Maharashtra, India, 411004
      • Pfizer Investigational Site
    • Pune, Maharashtra, India, 411 001
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1

Drug: voriconazole; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): January 10, 2011
• Last Update Submitted That Met QC Criteria: January 6, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Effectiveness; Observational study; Systemic Fungal Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: A1501089