A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00721578

Purpose

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.

Condition	Intervention
Systemic Fungal Infections	Drug: voriconazole

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Voriconazole

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Diagnosis of Systemic Fungal Infection (SFI) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
Number of participants with reason for investigator's selection of particular antifungal therapy.
Total Daily Dose for Selected Antifungal Agent [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
Number of Participants With Clinical Outcomes. [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
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:

Concomitant Medications [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
Median Duration of Antifungal Therapy [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
Medication Administration [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
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.

Enrollment:	23
Study Start Date:	April 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 Name: Vfend

Groups/Cohorts

Assigned Interventions

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 Name: Vfend

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721578

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00721578 History of Changes
Other Study ID Numbers:	A1501089
Study First Received:	July 22, 2008
Results First Received:	July 28, 2010
Last Updated:	January 6, 2011
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

Observational study
Effectiveness
Safety
Tolerability
Systemic Fungal Infection

Additional relevant MeSH terms:

Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012